Trial Outcomes & Findings for An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread (NCT NCT03377361)

Last Updated: 2025-12-03

Results Overview

Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

325 participants

Primary outcome timeframe

4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen

Results posted on

2025-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1 Cohort 1 Trame 1.5mg Cont	Part 1 Cohort 1B Trame 2 mg Int	Part 1 Cohort 1D Trame 2mg Cont	Part 1A Cohort 2 Trame 1.5mg Cont	Part 1A Cohort 2A Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 2 Treatment 1 Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 2 Regorafenib 80/160	Part 1B Nivo 6 + Ipi 1 + Trame 1.5
Pre-Treatment STARTED	3	3	6	7	3	3	7	124	61	82
Pre-Treatment COMPLETED	3	3	6	7	3	3	7	121	57	82
Pre-Treatment NOT COMPLETED	0	0	0	0	0	0	0	3	4	0
Treatment Period STARTED	3	3	6	7	3	3	7	121	57	82
Treatment Period COMPLETED	0	0	0	0	0	0	0	1	0	1
Treatment Period NOT COMPLETED	3	3	6	7	3	3	7	120	57	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 Cohort 1 Trame 1.5mg Cont	Part 1 Cohort 1B Trame 2 mg Int	Part 1 Cohort 1D Trame 2mg Cont	Part 1A Cohort 2 Trame 1.5mg Cont	Part 1A Cohort 2A Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 2 Treatment 1 Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 2 Regorafenib 80/160	Part 1B Nivo 6 + Ipi 1 + Trame 1.5
Pre-Treatment Subject withdrew consent	0	0	0	0	0	0	0	3	1	0
Pre-Treatment Not Reported	0	0	0	0	0	0	0	0	3	0
Treatment Period Disease Progression	3	2	5	3	3	3	6	106	48	59
Treatment Period Study Drug Toxicity	0	0	0	1	0	0	0	7	2	16
Treatment Period Death	0	0	1	0	0	0	0	2	1	3
Treatment Period Adverse Event Unrelated to Study Drug	0	0	0	0	0	0	1	2	3	0
Treatment Period Subject request to discontinue study treatment	0	0	0	0	0	0	0	0	1	1
Treatment Period Subject Withdrew Consent	0	0	0	0	0	0	0	0	2	1
Treatment Period No longer meets study criteria	0	1	0	0	0	0	0	1	0	0
Treatment Period Other Reasons	0	0	0	3	0	0	0	2	0	1

Baseline Characteristics

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 2 Treatment 1 n=124 Participants Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 2 n=61 Participants Regorafenib 80/160	Part 1B n=82 Participants Nivo 6 + Ipi 1 + Trame 1.5	Total n=299 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=3 Participants	3 Participants n=3 Participants	5 Participants n=6 Participants	6 Participants n=24 Participants	2 Participants n=15 Participants	3 Participants n=8 Participants	6 Participants n=7 Participants	89 Participants n=58 Participants	47 Participants n=202 Participants	60 Participants n=210 Participants	223 Participants n=187 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	1 Participants n=24 Participants	1 Participants n=15 Participants	0 Participants n=8 Participants	1 Participants n=7 Participants	35 Participants n=58 Participants	14 Participants n=202 Participants	22 Participants n=210 Participants	76 Participants n=187 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=58 Participants	0 Participants n=202 Participants	0 Participants n=210 Participants	0 Participants n=187 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	4 Participants n=24 Participants	2 Participants n=15 Participants	1 Participants n=8 Participants	3 Participants n=7 Participants	48 Participants n=58 Participants	30 Participants n=202 Participants	37 Participants n=210 Participants	129 Participants n=187 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	2 Participants n=3 Participants	6 Participants n=6 Participants	3 Participants n=24 Participants	1 Participants n=15 Participants	2 Participants n=8 Participants	4 Participants n=7 Participants	76 Participants n=58 Participants	31 Participants n=202 Participants	45 Participants n=210 Participants	170 Participants n=187 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	1 Participants n=24 Participants	0 Participants n=15 Participants	1 Participants n=8 Participants	0 Participants n=7 Participants	10 Participants n=58 Participants	6 Participants n=202 Participants	7 Participants n=210 Participants	25 Participants n=187 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	6 Participants n=24 Participants	3 Participants n=15 Participants	2 Participants n=8 Participants	7 Participants n=7 Participants	55 Participants n=58 Participants	27 Participants n=202 Participants	51 Participants n=210 Participants	163 Participants n=187 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants	59 Participants n=58 Participants	28 Participants n=202 Participants	24 Participants n=210 Participants	111 Participants n=187 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=58 Participants	0 Participants n=202 Participants	0 Participants n=210 Participants	0 Participants n=187 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	1 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	1 Participants n=7 Participants	2 Participants n=58 Participants	0 Participants n=202 Participants	5 Participants n=210 Participants	10 Participants n=187 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=58 Participants	0 Participants n=202 Participants	0 Participants n=210 Participants	0 Participants n=187 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants	1 Participants n=58 Participants	1 Participants n=202 Participants	1 Participants n=210 Participants	3 Participants n=187 Participants
Race (NIH/OMB) White	3 Participants n=3 Participants	3 Participants n=3 Participants	4 Participants n=6 Participants	6 Participants n=24 Participants	3 Participants n=15 Participants	2 Participants n=8 Participants	6 Participants n=7 Participants	119 Participants n=58 Participants	58 Participants n=202 Participants	74 Participants n=210 Participants	278 Participants n=187 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants	0 Participants n=58 Participants	0 Participants n=202 Participants	0 Participants n=210 Participants	0 Participants n=187 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=24 Participants	0 Participants n=15 Participants	1 Participants n=8 Participants	0 Participants n=7 Participants	2 Participants n=58 Participants	2 Participants n=202 Participants	2 Participants n=210 Participants	8 Participants n=187 Participants

PRIMARY outcome

Timeframe: 4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen

Population: All treated participants in Part 1 and Part 1A

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Dose Limiting Toxicities in Part 1 and Part 1A	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)

Population: All treated participants in Part 1 and Part 1A

Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Safety Related Events in Part 1 and Part 1 A Adverse Events (AEs)	6 Participants	7 Participants	3 Participants	3 Participants	7 Participants	3 Participants	3 Participants
Safety Related Events in Part 1 and Part 1 A Drug-Related AEs	6 Participants	7 Participants	3 Participants	3 Participants	7 Participants	3 Participants	3 Participants
Safety Related Events in Part 1 and Part 1 A Serious Adverse Events (SAEs)	4 Participants	3 Participants	0 Participants	2 Participants	3 Participants	2 Participants	0 Participants
Safety Related Events in Part 1 and Part 1 A Drug-Related SAEs	2 Participants	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Safety Related Events in Part 1 and Part 1 A Deaths	6 Participants	3 Participants	2 Participants	3 Participants	5 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)

Population: All treated participants in Part 1 and Part 1A

Number of participants with clinical laboratory abnormalities in specific thyroid tests

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH > ULN	1 Participants	3 Participants	1 Participants	3 Participants	2 Participants	2 Participants	1 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH > ULN WITH TSH ≤ ULN AT BASELINE	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH > ULN WITH FT3/FT4 TEST MISSING	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES ≥ LLN	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH < LLN	2 Participants	2 Participants	2 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH <LLN WITH TSH ≥ LLN AT BASELINE	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES ≤ ULN	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests TSH < LLN WITH FT3/FT4 TEST MISSING	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)

Population: All treated participants in Part 1 and Part 1A with atleast 1 On-Treatment Liver Test Measurement

Number of participants with clinical laboratory abnormalities in specific liver tests.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests ALT OR AST > 3XULN	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests ALT OR AST> 5XULN	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests ALT OR AST> 10XULN	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests ALT OR AST > 20XULN	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests TOTAL BILIRUBIN > 2XULN	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Approximately up to 30 Months

Population: All Randomized Participants in Part 1B and Part 2

ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=61 Participants Trame 2mg Cont	Part 1A Cohort 2 Trame 1.5mg Cont	Part 1A Cohort 2A Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 1 Cohort 1 n=82 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=124 Participants Trame 2 mg Int
Overal Response Rate in Part 1B and Part 2	1.6 Percentage of Participants Interval 0.0 to 8.8	—	—	—	—	9.8 Percentage of Participants Interval 4.3 to 18.3	1.6 Percentage of Participants Interval 0.2 to 5.7

SECONDARY outcome

Timeframe: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)

Population: All treated participants in Part 1 and Part 1A

ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Objective Response Rate in Part 1 and Part 1A	0 Percentage of Participants Interval 0.0 to 45.9	28.6 Percentage of Participants Interval 3.7 to 71.0	33.3 Percentage of Participants Interval 0.8 to 90.6	0 Percentage of Participants Interval 0.0 to 70.8	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 70.8	0 Percentage of Participants Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)

Population: All treated participants in Part 1 and Part 1A

The disease control rate (DCR) is defined as the percentage of participants whose BOR is either confirmed CR or confirmed PR or stable disease (SD)

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Disease Control Rate in Part 1 and Part 1A	50.0 Percentage of Participants Interval 11.8 to 88.2	57.1 Percentage of Participants Interval 18.4 to 90.1	33.3 Percentage of Participants Interval 0.8 to 90.6	66.7 Percentage of Participants Interval 9.4 to 99.2	28.6 Percentage of Participants Interval 3.7 to 71.0	66.7 Percentage of Participants Interval 9.4 to 99.2	33.3 Percentage of Participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: Approximately up to 20 Months

Population: All treated participants in Part 1 and Part 1A who had a response

DOR for a participant with a BOR of confirmed CR or PR, is defined as the time between the date of first confirmed response and the date of the first objectively documented tumor progression per RECIST 1.1 or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D Trame 2mg Cont	Part 1A Cohort 2 n=2 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=1 Participants Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 1 Cohort 1 Trame 1.5mg Cont	Part 1 Cohort 1B Trame 2 mg Int
Duration of Response in Part 1 and Part 1A	—	9.46 Months Insufficient number of events to calculate via KM Methodology.	19.42 Months Insufficient number of events to calculate via KM methodology.	—	—	—	—

SECONDARY outcome

Timeframe: From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)

Population: All treated participants in Part 1 and Part 1A who had a response

Time to response (TTR) is defined for participants who had a confirmed CR or PR as the time from the first dosing date to the date of first documented CR or PR per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D Trame 2mg Cont	Part 1A Cohort 2 n=2 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=1 Participants Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 1 Cohort 1 Trame 1.5mg Cont	Part 1 Cohort 1B Trame 2 mg Int
Time to Response in Part 1 and Part 1A	—	5.63 Months Interval 1.8 to 9.5	1.54 Months Interval 1.54 to 1.54	—	—	—	—

SECONDARY outcome

Timeframe: from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)

Population: All treated participants in Part 1 and Part 1A

PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression per RECIST 1.1 (ie, radiologic) or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Progression Free Survival in Part 1 and Part 1A	2.66 Months Interval 0.79 to Insufficient number of participants with events to calculate via KM methodology	7.36 Months Interval 1.84 to Insufficient number of participants with events to calculate via KM methodology	1.74 Months Interval 1.74 to Insufficient number of participants with events to calculate via KM methodology	4.14 Months Interval 1.84 to Insufficient number of participants with events to calculate via KM methodology	1.81 Months Interval 0.92 to Insufficient number of participants with events to calculate via KM methodology	3.58 Months Interval 1.84 to Insufficient number of participants with events to calculate via KM methodology	1.91 Months Interval 1.74 to Insufficient number of participants with events to calculate via KM methodology

SECONDARY outcome

Timeframe: Approximately up to 69 Months

Population: All treated participants in Part 1 and Part 1A

OS for a participant is defined as the time from the first dosing date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=6 Participants Trame 2mg Cont	Part 1A Cohort 2 n=7 Participants Trame 1.5mg Cont	Part 1A Cohort 2A n=3 Participants Trame 1mg Cont	Part 1A Cohort 3 n=3 Participants Trame 1.5mg Int	Part 1A Cohort 3B n=7 Participants Trame 2mg Int	Part 1 Cohort 1 n=3 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=3 Participants Trame 2 mg Int
Overall Survival in Part 1 and Part 1A	9.61 Months Interval 0.89 to Insufficient number of participants with events to calculate via KM methodology	42.09 Months Interval 11.6 to Insufficient number of participants with events to calculate via KM methodology	19.02 Months Interval 8.8 to Insufficient number of participants with events to calculate via KM methodology	11.33 Months Interval 10.51 to Insufficient number of participants with events to calculate via KM methodology	36.24 Months Interval 2.23 to Insufficient number of participants with events to calculate via KM methodology	8.99 Months Interval 8.8 to Insufficient number of participants with events to calculate via KM methodology	18.50 Months Interval 17.45 to Insufficient number of participants with events to calculate via KM methodology

SECONDARY outcome

Timeframe: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)

Population: All Treated Participants in Part 1B and Part 2

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=57 Participants Trame 2mg Cont	Part 1A Cohort 2 Trame 1.5mg Cont	Part 1A Cohort 2A Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 1 Cohort 1 n=82 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=121 Participants Trame 2 mg Int
Safety Related Events in Part 1B and Part 2 Adverse Events (AEs)	57 Participants	—	—	—	—	82 Participants	121 Participants
Safety Related Events in Part 1B and Part 2 Drug-Related AEs	52 Participants	—	—	—	—	80 Participants	116 Participants
Safety Related Events in Part 1B and Part 2 Serious Adverse Events (SAEs)	19 Participants	—	—	—	—	36 Participants	56 Participants
Safety Related Events in Part 1B and Part 2 Drug-Related SAEs	3 Participants	—	—	—	—	20 Participants	21 Participants
Safety Related Events in Part 1B and Part 2 Deaths	53 Participants	—	—	—	—	49 Participants	106 Participants

SECONDARY outcome

Timeframe: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)

Population: All Treated Participants in Part 1B and Part 2 with atleast 1 On-Treatment TSH Measurement

Number of participants with clinical laboratory abnormalities in specific thyroid tests

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=46 Participants Trame 2mg Cont	Part 1A Cohort 2 Trame 1.5mg Cont	Part 1A Cohort 2A Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 1 Cohort 1 n=81 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=114 Participants Trame 2 mg Int
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	0 Participants	—	—	—	—	5 Participants	12 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH > ULN WITH FT3/FT4 TEST MISSING	4 Participants	—	—	—	—	1 Participants	4 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH < LLN	0 Participants	—	—	—	—	14 Participants	24 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH > ULN	21 Participants	—	—	—	—	13 Participants	31 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH > ULN WITH TSH ≤ ULN AT BASELINE	16 Participants	—	—	—	—	9 Participants	18 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	3 Participants	—	—	—	—	9 Participants	14 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES ≥ LLN	14 Participants	—	—	—	—	3 Participants	13 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH <LLN WITH TSH ≥ LLN AT BASELINE	0 Participants	—	—	—	—	11 Participants	21 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES ≤ ULN	0 Participants	—	—	—	—	8 Participants	7 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests TSH < LLN WITH FT3/FT4 TEST MISSING	0 Participants	—	—	—	—	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)

Population: All Treated Participants in Part 1B and Part 2 with atleast 1 On-Treatment Liver test Measurement

Number of participants with clinical laboratory abnormalities in specific liver tests.

Outcome measures

Outcome measures
Measure	Part 1 Cohort 1D n=57 Participants Trame 2mg Cont	Part 1A Cohort 2 Trame 1.5mg Cont	Part 1A Cohort 2A Trame 1mg Cont	Part 1A Cohort 3 Trame 1.5mg Int	Part 1A Cohort 3B Trame 2mg Int	Part 1 Cohort 1 n=82 Participants Trame 1.5mg Cont	Part 1 Cohort 1B n=121 Participants Trame 2 mg Int
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	7 Participants	—	—	—	—	2 Participants	6 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	7 Participants	—	—	—	—	2 Participants	7 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests ALT OR AST > 20XULN	2 Participants	—	—	—	—	0 Participants	3 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests TOTAL BILIRUBIN > 2XULN	12 Participants	—	—	—	—	3 Participants	9 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests ALT OR AST > 3XULN	11 Participants	—	—	—	—	18 Participants	38 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests ALT OR AST> 5XULN	8 Participants	—	—	—	—	8 Participants	19 Participants
Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests ALT OR AST> 10XULN	4 Participants	—	—	—	—	1 Participants	5 Participants

Adverse Events

Part 1 Cohort 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1 Cohort 1B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1 Cohort 1D

Serious events: 5 serious events

Other events: 6 other events

Deaths: 6 deaths

Part 1A Cohort 2

Serious events: 3 serious events

Other events: 7 other events

Deaths: 3 deaths

Part 1A Cohort 2A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1A Cohort 3

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1A Cohort 3B

Serious events: 3 serious events

Other events: 7 other events

Deaths: 5 deaths

Part 1B

Serious events: 42 serious events

Other events: 82 other events

Deaths: 49 deaths

Part 2 Treatment 1

Serious events: 79 serious events

Other events: 121 other events

Deaths: 108 deaths

Part 2 Treatment 2

Serious events: 33 serious events

Other events: 55 other events

Deaths: 55 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 Cohort 1 n=3 participants at risk Trame 1.5 mg Cont	Part 1 Cohort 1B n=3 participants at risk Trame 2 mg Int	Part 1 Cohort 1D n=6 participants at risk Trame 2 mg Cont	Part 1A Cohort 2 n=7 participants at risk Trame 1.5 mg Cont	Part 1A Cohort 2A n=3 participants at risk Trame 1 mg Cont	Part 1A Cohort 3 n=3 participants at risk Trame 1.5 mg Int	Part 1A Cohort 3B n=7 participants at risk Trame 2 mg Int	Part 1B n=82 participants at risk Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 1 n=121 participants at risk Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 2 n=57 participants at risk Regorafenib 80/160
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac arrest	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac failure	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypothyroidism	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Detachment of retinal pigment epithelium	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Eyelid ptosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Anal fistula	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Ascites	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Colitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Enteritis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrooesophageal haemorrhage	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Ileus	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Intestinal perforation	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Rectal perforation	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Cardiac death	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Disease progression	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Influenza like illness	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Localised oedema	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Non-cardiac chest pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.8% 7/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Acute cholecystitis necrotic	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Acute hepatic failure	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Biliary cast syndrome	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Jaundice	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Liver disorder	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Malignant biliary obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bacteraemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Clostridium difficile colitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Listeriosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia pneumococcal	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Proteus infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sepsis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Septic shock	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Soft tissue infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Stoma site abscess	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Stoma site infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Streptococcal infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urosepsis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Vascular device infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Lipase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Limb injury	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Amylase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood bilirubin increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood creatinine increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood lactic acid increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Ejection fraction decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Seizure	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.4% 11/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	34.7% 42/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	36.8% 21/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to eye	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hyponatraemic encephalopathy	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Spinal cord compression	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Syncope	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Confusional state	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Delirium	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Mental status changes	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Embolism	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Extrinsic iliac vein compression	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Other adverse events
Measure	Part 1 Cohort 1 n=3 participants at risk Trame 1.5 mg Cont	Part 1 Cohort 1B n=3 participants at risk Trame 2 mg Int	Part 1 Cohort 1D n=6 participants at risk Trame 2 mg Cont	Part 1A Cohort 2 n=7 participants at risk Trame 1.5 mg Cont	Part 1A Cohort 2A n=3 participants at risk Trame 1 mg Cont	Part 1A Cohort 3 n=3 participants at risk Trame 1.5 mg Int	Part 1A Cohort 3B n=7 participants at risk Trame 2 mg Int	Part 1B n=82 participants at risk Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 1 n=121 participants at risk Nivo 6 + Ipi 1 + Trame 1.5	Part 2 Treatment 2 n=57 participants at risk Regorafenib 80/160
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	50.0% 3/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.0% 18/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	29.8% 36/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.1% 12/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac disorder	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Palpitations	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Sinus bradycardia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Tachycardia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hyperthyroidism	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypothyroidism	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Diplopia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Dry eye	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Iridocyclitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Ocular hyperaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Retinopathy	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Subretinal fluid	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Swelling of eyelid	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Uveitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Vision blurred	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Visual impairment	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.0% 18/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.0% 17/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.8% 9/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Ascites	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.8% 7/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	50.0% 3/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.2% 10/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.0% 17/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.8% 13/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 4/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	85.7% 6/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	54.9% 45/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	43.0% 52/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	38.6% 22/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.8% 7/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.8% 7/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Flatulence	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	71.4% 5/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	71.4% 5/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	31.7% 26/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	45.5% 55/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.8% 9/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Proctalgia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Stomatitis	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 10/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.0% 8/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.7% 17/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	29.8% 36/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.1% 14/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.6% 31/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.1% 16/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Chills	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Early satiety	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 4/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	100.0% 7/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	85.7% 6/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	40.2% 33/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.1% 51/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	38.6% 22/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Gait disturbance	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Influenza like illness	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Malaise	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Mucosal inflammation	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.8% 7/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.8% 9/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	50.0% 3/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.6% 31/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.7% 17/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	23.1% 28/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.8% 13/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Thirst	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Xerosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 8/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Candida infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Gingivitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Mucosal infection	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Paronychia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Rash pustular	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.8% 7/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Burns first degree	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Thermal burn	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.1% 14/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	23.1% 28/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.8% 13/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	24.4% 20/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	30.6% 37/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	29.8% 17/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood albumin decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.7% 13/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 10/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood bilirubin increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.2% 16/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 19/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood calcium decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood creatinine increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood magnesium decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood phosphorus decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood potassium decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood sodium decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 10/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood thyroid stimulating hormone increased	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.3% 7/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Ejection fraction decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 8/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Lipase increased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Lymphocyte count decreased	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Platelet count decreased	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight decreased	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.0% 17/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.5% 10/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations White blood cell count decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 4/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.9% 13/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	26.4% 32/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	26.3% 15/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Dehydration	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.1% 11/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.5% 10/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	50.0% 3/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.9% 12/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.0% 8/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.1% 11/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dysgeusia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 10/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.0% 4/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral ischaemia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Disturbance in attention	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 8/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dyskinesia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.9% 13/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.3% 7/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Presyncope	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Taste disorder	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Anxiety	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Confusional state	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.1% 11/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Dysuria	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Haematuria	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.0% 6/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Proteinuria	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.6% 14/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.5% 10/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	19.0% 23/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Flushing	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.3% 3/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Dermatitis acneiform	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	83.3% 5/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	100.0% 3/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	85.7% 6/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	24.4% 20/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	32.2% 39/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Drug eruption	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Dry skin	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.5% 2/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	43.9% 25/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Photosensitivity reaction	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	32.9% 27/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.6% 31/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.8% 5/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 1/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	47.6% 39/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.1% 51/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	66.7% 2/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	19.5% 16/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.7% 13/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.5% 6/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash pruritic	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.7% 2/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hot flush	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.83% 1/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 2/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.9% 13/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 10/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.3% 7/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypotension	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	33.3% 1/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.8% 1/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Vena cava thrombosis	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/6 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/3 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/121 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/57 • Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER