Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors (NCT NCT04049617)

NCT ID: NCT04049617

Last Updated: 2022-10-06

Results Overview

A DLT was any toxicity defined as follows excluding toxicities clearly related to disease progression or disease-related processes occurring during the DLT assessment window (Day 1 through Day 21): * Grade ≥ 4 neutropenia * Grade ≥ 3 neutropenia with fever * Grade ≥ 3 thrombocytopenia * Grade ≥ 2 bleeding * Grade ≥ 3 anemia * Grade ≥ 3 or higher non-hematologic toxicity (excluding Grade 3 nausea or emesis or Grade 3 diarrhea) * Grade ≥ 2 non-hematologic treatment-emergent adverse event that in the opinion of the investigator is of potential clinical significance * Treatment interruption of ≥ 7 days due to unresolved toxicity * Any toxicity event that precludes further administration of evixapodlin * Any Grade 3 or Grade 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin lasting ≥ 7 days * An immune-related adverse event (irAE) for which immunotherapy should be permanently discontinued

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 18 participants
• Primary outcome timeframe: Day 1 through Day 21
• Results posted on: 2022-10-06

Participant Flow

Participants were enrolled at study sites in New Zealand and the United States. The first participant was screened on 26 August 2019. The last study visit occurred on 30 March 2021.

29 participants were screened. The participants took part in the Phase 1 (Dose Escalation) of the study only. No participants were enrolled in the Phase 1 Cohort 5 and Cohort 2 substudy and the study was terminated due to sponsor decision before the planned Dose Expansion Phase 2 started.

Participant milestones

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Overall Study STARTED	3	3	6	3	2	1
Overall Study COMPLETED	3	3	5	1	2	0
Overall Study NOT COMPLETED	0	0	1	2	0	1

Reasons for withdrawal

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Overall Study Adverse Event	0	0	0	1	0	0
Overall Study Death	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	1	0	0
Overall Study Withdrew consent	0	0	1	0	0	0

Baseline Characteristics

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=3 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 Participants Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 Participants Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) n=2 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) n=1 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Total n=18 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 28.29 • n=5 Participants	65.3 years STANDARD_DEVIATION 15.53 • n=7 Participants	61.2 years STANDARD_DEVIATION 5.67 • n=5 Participants	70.0 years STANDARD_DEVIATION 11.53 • n=4 Participants	64.0 years STANDARD_DEVIATION 12.73 • n=21 Participants	42.0 years STANDARD_DEVIATION NA • n=10 Participants	61.6 years STANDARD_DEVIATION 14.23 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	15 Participants n=115 Participants
Race/Ethnicity, Customized Race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants	NA Participants n=10 Participants	NA Participants n=115 Participants
Race/Ethnicity, Customized Ethnicity	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants	NA Participants n=10 Participants	NA Participants n=115 Participants
Region of Enrollment New Zealand	1 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	0 participants n=10 Participants	12 participants n=115 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	6 participants n=115 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 21

Population: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.

A DLT was any toxicity defined as follows excluding toxicities clearly related to disease progression or disease-related processes occurring during the DLT assessment window (Day 1 through Day 21):

• Grade ≥ 4 neutropenia
• Grade ≥ 3 neutropenia with fever
• Grade ≥ 3 thrombocytopenia
• Grade ≥ 2 bleeding
• Grade ≥ 3 anemia
• Grade ≥ 3 or higher non-hematologic toxicity (excluding Grade 3 nausea or emesis or Grade 3 diarrhea)
• Grade ≥ 2 non-hematologic treatment-emergent adverse event that in the opinion of the investigator is of potential clinical significance
• Treatment interruption of ≥ 7 days due to unresolved toxicity
• Any toxicity event that precludes further administration of evixapodlin
• Any Grade 3 or Grade 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin lasting ≥ 7 days
• An immune-related adverse event (irAE) for which immunotherapy should be permanently discontinued

Outcome measures

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=3 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 Participants Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 Participants Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) n=2 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) n=1 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) During the Dose Escalation Phase	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 hours (h) postdose (400-1500 once daily [QD] mg cohorts) on Cycle (C) 1 Day (D) 1 & D15

Population: PK Analysis Set included participants in the Safety Analysis Set who had received the study drug and have at least 1 sample with detectable drug concentration. Data for Cohort 1 included participants from Cohort 1 and Substudy Cohort 1. PK data were not collected for Cohort 3 Substudy group due to discontinuation of the development program.

AUCtau was defined as area under the concentration-time curve from time zero to the end of the dosing interval.

Outcome measures

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=5 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 Participants Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 Participants Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Pharmacokinetic (PK) Parameter: AUCtau of Evixapodlin During the Dose Escalation Phase C1D1	6543.1 h*ng/mL Standard Deviation 1783.07	8703.8 h*ng/mL Standard Deviation 3717.93	12241.8 h*ng/mL Standard Deviation 2793.17	19132.6 h*ng/mL Standard Deviation 596.64	—	—
Pharmacokinetic (PK) Parameter: AUCtau of Evixapodlin During the Dose Escalation Phase C1D15	9269.8 h*ng/mL Standard Deviation 2693.53	13508.4 h*ng/mL Standard Deviation 3126.80	19380.8 h*ng/mL Standard Deviation 5261.89	27664.5 h*ng/mL Standard Deviation 7758.37	—	—

SECONDARY outcome

Timeframe: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15

Population: Participants in PK Analysis Set were analyzed. Data for Cohort 1 included participants from Cohort 1 and Substudy Cohort 1. PK data were not collected for Cohort 3 Substudy group due to discontinuation of the development program.

Cmax was defined as the maximum observed drug concentration.

Outcome measures

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=5 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 Participants Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 Participants Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
PK Parameter: Cmax of Evixapodlin During the Dose Escalation Phase C1D1	1090.4 ng/mL Standard Deviation 355.12	1468.7 ng/mL Standard Deviation 497.74	1918.3 ng/mL Standard Deviation 377.59	2116.7 ng/mL Standard Deviation 55.08	—	—
PK Parameter: Cmax of Evixapodlin During the Dose Escalation Phase C1D15	1193.8 ng/mL Standard Deviation 605.87	1580.0 ng/mL Standard Deviation 245.76	2051.7 ng/mL Standard Deviation 686.89	2480.0 ng/mL Standard Deviation 278.75	—	—

SECONDARY outcome

Timeframe: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15

Population: Participants in the PK Analysis Set were analyzed. Data for Cohort 1 included participants from Cohort 1 and Substudy Cohort 1. PK data were not collected for Cohort 3 Substudy group due to discontinuation of the development program.

Ctrough is defined as the observed concentration at the end of the dosing interval.

Outcome measures

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=5 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 Participants Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 Participants Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
PK Parameter: Ctrough of Evixapodlin During the Dose Escalation Phase C1D1	40.3 ng/mL Standard Deviation 9.80	56.2 ng/mL Standard Deviation 18.05	111.9 ng/mL Standard Deviation 43.92	180.3 ng/mL Standard Deviation 21.50	—	—
PK Parameter: Ctrough of Evixapodlin During the Dose Escalation Phase C1D15	109.8 ng/mL Standard Deviation 35.61	198.7 ng/mL Standard Deviation 57.98	318.5 ng/mL Standard Deviation 88.44	472.7 ng/mL Standard Deviation 112.88	—	—

SECONDARY outcome

Timeframe: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15

Population: Participants in PK Analysis Set were analyzed. Data for Cohort 1 included participants from Cohort 1 and Substudy Cohort 1. PK data were not collected for Cohort 3 Substudy group due to discontinuation of the development program.

Tmax is defined as the time to maximum observed concentration.

Outcome measures

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=5 Participants Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 Participants Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 Participants Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 Participants Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
PK Parameter: Tmax of Evixapodlin During the Dose Escalation Phase C1D1	1.00 hours Interval 1.0 to 1.02	1.53 hours Interval 1.0 to 2.5	1.52 hours Interval 1.0 to 1.65	2.50 hours Interval 2.5 to 6.0	—	—
PK Parameter: Tmax of Evixapodlin During the Dose Escalation Phase C1D15	1.50 hours Interval 1.0 to 2.02	1.50 hours Interval 1.0 to 1.5	1.51 hours Interval 1.0 to 2.5	4.00 hours Interval 1.5 to 5.95	—	—

SECONDARY outcome

Timeframe: First dose date through end of treatment plus 30 days, approximately 5 years

Population: The study was closed due to sponsor decision prior to opening the dose expansion phase. Hence, no participants were analyzed in this phase.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First dose date through end of treatment plus 30 days, approximately 5 years

Population: The study was closed due to sponsor decision prior to opening the dose expansion phase. Hence, no participants were analyzed in this phase.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: Evixapodlin 400 mg (Phase 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2: Evixapodlin 700 mg (Phase 1)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3: Evixapodlin 1000 mg (Phase 1)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 4: Evixapodlin 1500 mg (Phase 1)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=3 participants at risk Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 participants at risk Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 participants at risk Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 participants at risk Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) n=2 participants at risk Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) n=1 participants at risk Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Rectal perforation	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	100.0% 1/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
General disorders Pyrexia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Infections and infestations Norovirus infection	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Infections and infestations Sepsis	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	100.0% 1/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.

Other adverse events

Measure	Cohort 1: Evixapodlin 400 mg (Phase 1) n=3 participants at risk Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 21 weeks).	Cohort 2: Evixapodlin 700 mg (Phase 1) n=3 participants at risk Participants received evixapodlin 700 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).	Cohort 3: Evixapodlin 1000 mg (Phase 1) n=6 participants at risk Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 4: Evixapodlin 1500 mg (Phase 1) n=3 participants at risk Participants received evixapodlin 1500 mg once daily for 21 days of each cycle (observed maximum duration was approximately 19 weeks).	Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) n=2 participants at risk Participants received evixapodlin 400 mg once daily for 21 days of each cycle (observed maximum duration was approximately 39 weeks).	Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) n=1 participants at risk Participants received evixapodlin 1000 mg once daily for 21 days of each cycle (observed maximum duration was approximately 10 weeks).
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Constipation	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 2/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	66.7% 4/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	66.7% 2/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	50.0% 1/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Gastritis	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Ileus	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Nausea	100.0% 3/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	66.7% 2/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	66.7% 4/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	66.7% 2/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	50.0% 1/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Gastrointestinal disorders Vomiting	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	66.7% 2/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
General disorders Chest pain	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	50.0% 1/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
General disorders Chills	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
General disorders Fatigue	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	50.0% 1/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
General disorders Oedema peripheral	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Infections and infestations Postoperative wound infection	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Infections and infestations Respiratory tract infection	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Investigations Weight decreased	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	50.0% 1/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Nervous system disorders Ageusia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Nervous system disorders Dizziness	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Nervous system disorders Migraine	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Nervous system disorders Presyncope	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 2/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Nervous system disorders Syncope	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Psychiatric disorders Depression	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Psychiatric disorders Insomnia	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	50.0% 1/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 2/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	16.7% 1/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
Vascular disorders Thrombophlebitis superficial	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/6 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	33.3% 1/3 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/2 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.	0.00% 0/1 • All-Cause Mortality: Enrollment up to 46.1 weeks Adverse Events: First dose date up to last dose (maximum: 39.1 weeks) plus 30 days All-Cause Mortality: All Enrolled Analysis Set included all participants who received a study identification number in the study after screening. Adverse Events: Safety Analysis Set included data from all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER