Trial Outcomes & Findings for Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer (NCT NCT04958785)

Last Updated: 2025-11-04

Results Overview

PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD), as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

Up to 107 weeks

Results posted on

2025-11-04

Participant Flow

Participants were enrolled at study sites in Republic of Korea, Taiwan, Australia, Hong Kong, United States, and the United Kingdom.

129 participants were screened.

Participant milestones

Participant milestones
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks;	Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below: * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks;	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks;	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks;
Overall Study STARTED	8	14	14	13	43
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	8	14	14	13	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks;	Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below: * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks;	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks;	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks;
Overall Study Study Terminated by Sponsor	4	10	7	6	34
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Death	2	3	4	5	5
Overall Study Withdrew consent	2	0	3	1	0
Overall Study Investigator's discretion	0	1	0	1	2
Overall Study Adverse Event	0	0	0	0	1

Baseline Characteristics

Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=8 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Runi-in Cohort 1.	Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel n=14 Participants Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.	Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel n=14 Participants Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below: * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Total n=91 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	5 Participants n=15 Participants	10 Participants n=161 Participants	12 Participants n=100 Participants	11 Participants n=3 Participants	36 Participants n=8 Participants	74 Participants n=7 Participants
Age, Categorical >=65 years	3 Participants n=15 Participants	4 Participants n=161 Participants	2 Participants n=100 Participants	2 Participants n=3 Participants	6 Participants n=8 Participants	17 Participants n=7 Participants
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants
Age, Continuous	54 years STANDARD_DEVIATION 11.5 • n=15 Participants	58 years STANDARD_DEVIATION 12.8 • n=161 Participants	52 years STANDARD_DEVIATION 13.3 • n=100 Participants	53 years STANDARD_DEVIATION 10.0 • n=3 Participants	53 years STANDARD_DEVIATION 11.2 • n=8 Participants	54 years STANDARD_DEVIATION 11.6 • n=7 Participants
Sex: Female, Male Female	8 Participants n=15 Participants	13 Participants n=161 Participants	14 Participants n=100 Participants	13 Participants n=3 Participants	41 Participants n=8 Participants	89 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants	2 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	1 Participants n=3 Participants	0 Participants n=8 Participants	2 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	2 Participants n=8 Participants	3 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=15 Participants	12 Participants n=161 Participants	14 Participants n=100 Participants	12 Participants n=3 Participants	40 Participants n=8 Participants	86 Participants n=7 Participants
Race (NIH/OMB) Asian	2 Participants n=15 Participants	6 Participants n=161 Participants	10 Participants n=100 Participants	2 Participants n=3 Participants	29 Participants n=8 Participants	49 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants	1 Participants n=7 Participants
Region of Enrollment Hong Kong	2 Participants n=15 Participants	4 Participants n=161 Participants	4 Participants n=100 Participants	0 Participants n=3 Participants	3 Participants n=8 Participants	13 Participants n=7 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants	0 Participants n=161 Participants	1 Participants n=100 Participants	2 Participants n=3 Participants	0 Participants n=8 Participants	4 Participants n=7 Participants
Race (NIH/OMB) White	5 Participants n=15 Participants	6 Participants n=161 Participants	3 Participants n=100 Participants	8 Participants n=3 Participants	12 Participants n=8 Participants	34 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	1 Participants n=3 Participants	0 Participants n=8 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	1 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants	1 Participants n=7 Participants
Region of Enrollment South Korea	0 Participants n=15 Participants	2 Participants n=161 Participants	4 Participants n=100 Participants	0 Participants n=3 Participants	18 Participants n=8 Participants	24 Participants n=7 Participants
Region of Enrollment United States	2 Participants n=15 Participants	5 Participants n=161 Participants	3 Participants n=100 Participants	7 Participants n=3 Participants	12 Participants n=8 Participants	29 Participants n=7 Participants
Region of Enrollment Taiwan	0 Participants n=15 Participants	0 Participants n=161 Participants	2 Participants n=100 Participants	1 Participants n=3 Participants	7 Participants n=8 Participants	10 Participants n=7 Participants
Region of Enrollment United Kingdom	0 Participants n=15 Participants	2 Participants n=161 Participants	0 Participants n=100 Participants	2 Participants n=3 Participants	2 Participants n=8 Participants	6 Participants n=7 Participants
Region of Enrollment Australia	4 Participants n=15 Participants	1 Participants n=161 Participants	1 Participants n=100 Participants	3 Participants n=3 Participants	0 Participants n=8 Participants	9 Participants n=7 Participants

PRIMARY outcome

Timeframe: First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2)

Population: DLT-Evaluable Analysis Set included all participants who meet 1 of the following criteria: * Participant experienced a DLT at any time after initiation of the first infusion of magrolimab. * Participant did not experience a DLT and completed at least 3 infusions of magrolimab (28-day cycle), and at least 2 doses of nab-paclitaxel or paclitaxel (Safety Run-in Cohort 1 (SRiC1)), at least 2 infusions of magrolimab (21-day cycle), and at least 2 infusions of sacituzumab govitecan (SRiC2).

A DLT is defined as any: * Grade 3 or higher hematologic toxicity including: * Hemolytic anemia that is medically significant, requiring hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care activities of daily life. * Event meeting Hy's Law criteria: * Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (at least 3 x ULN), AND * Treatment-emergent total bilirubin elevation (more than 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase less than 2 x ULN), AND * No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases). * Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT assessment period, and in the opinion of the investigator, the AE is at least possibly related to magrolimab.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=6 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)	0 percentage of participants	0 percentage of participants	—	—

PRIMARY outcome

Timeframe: First dose date up to last dose date (up to 73 weeks) plus 30 days

Population: The Safety Analysis Set in the Safety Run-in Cohorts 1 and 2 included all participants who took at least 1 dose of any study drug.

TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=8 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	100.0 percentage of participants	100.0 percentage of participants	—	—

PRIMARY outcome

Timeframe: First dose date up to last dose date (up to 73 weeks) plus 30 days

Population: Participants in the Safety Run-in Cohorts 1 and 2 in the Safety Analysis Set were analyzed.

Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy. Grade 1 mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening and Grade 5 death. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=8 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 Any Grade	100.0 percentage of participants	100.0 percentage of participants	—	—
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 Grade 3 or 4	62.5 percentage of participants	84.6 percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to 107 weeks

Population: Participants from Phase 2 Cohort 1 in the Intent-to-treat (ITT) Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=14 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=14 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	13.9 months Interval 3.5 to Upper limit of CI was not estimable due to low number of participants with events.	10.0 months Interval 1.0 to Upper limit of CI was not estimable due to low number of participants with events.	—	—

PRIMARY outcome

Timeframe: Up to 107 weeks

Population: Participants in the modified Intent-To-Treat (mITT) Analysis Set (Cohort 2) were analyzed.

ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as determined at least 4 weeks after initial documentation of response by investigator assessment per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=13 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Safety Run-in Cohort 2 and Phase 2 Cohort 2: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	30.8 percentage of participants Interval 9.1 to 61.4	38.1 percentage of participants Interval 23.6 to 54.4	—	—

SECONDARY outcome

Timeframe: Up to 107 weeks

Population: Participants from the Phase 2 Cohort 1 in the ITT Analysis Set were analyzed.

ORR is defined as the percentage of participants who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response, as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=14 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=14 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1	35.7 percentage of participants Interval 12.8 to 64.9	21.4 percentage of participants Interval 4.7 to 50.8	—	—

SECONDARY outcome

Timeframe: Up to 107 weeks

Population: Participants in the mITT Analysis Set (Cohort 2) were analyzed.

PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=13 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1	7.1 months Interval 1.4 to Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.	5.5 months Interval 4.0 to Upper limit of CI was not estimable due to low number of participants with events.	—	—

SECONDARY outcome

Timeframe: Up to 107 weeks

Population: Participants in the ITT Analysis Set (Cohort 1) and mITT Analysis Set (Cohort 2) with objective response were analyzed.

DOR is defined as time from first documentation of CR or PR to the earliest date of documented PD, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=5 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=3 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=4 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan n=16 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1	12.2 months Interval 3.1 to Upper limit of CI were not estimable due to low number of participants with events.	NA months Interval 9.2 to Median and upper limit of CI were not estimable due to low number of participants with events.	NA months Interval 9.0 to Median and upper limit of CI were not estimable due to low number of participants with events.	NA months Interval 2.8 to Median and upper limit of CI were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Up to 107 weeks

Population: Participants in the ITT Analysis Set (Cohort 1) and mITT Analysis Set (Cohort 2) were analyzed.

OS is defined as time from date of randomization to death from any cause.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=14 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=14 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Overall Survival (OS)	NA months Interval 8.9 to Median and upper limit of CI were not estimable due to low number of participants with events.	NA months Interval 2.4 to Median and upper limit of CI were not estimable due to low number of participants with events.	15.7 months Interval 8.5 to Upper limit of CI was not estimable due to low number of participants with events.	NA months Median, lower and upper limit of CI were not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: First dose date up to last dose date (up to 73 weeks) plus 30 days

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=14 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs	100.0 percentage of participants	100.0 percentage of participants	97.6 percentage of participants	—

SECONDARY outcome

Timeframe: First dose date up to last dose date (up to 73 weeks) plus 30 days

Population: Participants in the Safety Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=14 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0 Any Grade	100.0 percentage of participants	84.6 percentage of participants	100.0 percentage of participants	—
Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing Laboratory Abnormalities According to NCI CTCAE, Version 5.0 Grade 3 or 4	64.3 percentage of participants	7.7 percentage of participants	78.6 percentage of participants	—

SECONDARY outcome

Timeframe: Cohort 1: Predose - Day 1, 8, 22, 43, 85, 127, 190 and 253, Postdose 1 hour - Day 8 and 43; Cohort 2: Predose - Day 1, 8, 22, 43, 64, 85, 127, 190 and 253, Postdose 1 hour - Day 43 and 64

Population: Participants in the Pharmacokinetic (PK) Analysis set with available data were analyzed. The PK Analysis Set included all participants who received any amount of magrolimab and have at least 1 evaluable post-treatment serum concentration of magrolimab. PK of magrolimab was evaluated in 2 combination therapy cohorts: Cohort 1 (Safety Run-in Cohort 1, and Phase 2 Cohort 1 Arm A), and Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2). The combined PK data were summarized and reported.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=21 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=53 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 43 1-Hour Postdose	1520 μg/mL Standard Deviation 415	1670 μg/mL Standard Deviation 592	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 64 Predose	—	490 μg/mL Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 64 1-Hour Postdose	—	424 μg/mL Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 85 Predose	394 μg/mL Standard Deviation 178	414 μg/mL Standard Deviation 188	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 127 Predose	303 μg/mL Standard Deviation 77.3	382 μg/mL Standard Deviation 148	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 253 Predose	294 μg/mL Standard Deviation 65.8	498 μg/mL Standard Deviation 112	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 190 Predose	263 μg/mL Standard Deviation 124	373 μg/mL Standard Deviation 272	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 1 Predose	NA μg/mL Standard Deviation NA Predose data was not reported as it was below the limit of quantification.	NA μg/mL Standard Deviation NA Predose data was not reported as it was below the limit of quantification.	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 8 Predose	0.0700 μg/mL Standard Deviation 0.263	NA μg/mL Standard Deviation NA Predose data was not reported as it was below the limit of quantification.	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 8 1-Hour Postdose	289 μg/mL Standard Deviation 164	—	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 22 Predose	559 μg/mL Standard Deviation 218	306 μg/mL Standard Deviation 129	—	—
Cohort 1 (Safety Run-in and Phase 2) and Cohort 2 (Safety Run-in and Phase 2): Concentration Levels of Magrolimab Over Time Day 43 Predose	862 μg/mL Standard Deviation 322	585 μg/mL Standard Deviation 193	—	—

SECONDARY outcome

Timeframe: Up to 73 weeks

Population: Participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set included all participants who received any amount of magrolimab and have at least 1 evaluable anti-magrolimab antibody test results.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=8 Participants Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=14 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 Participants Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab ADA Prevalence	12.5 percentage of participants	7.1 percentage of participants	15.4 percentage of participants	4.8 percentage of participants
Percentage of Participants With Antidrug Antibodies (ADA) to Magrolimab ADA Incidence	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

Adverse Events

Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel

Serious events: 5 serious events

Other events: 8 other events

Deaths: 2 deaths

Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel

Serious events: 4 serious events

Other events: 14 other events

Deaths: 3 deaths

Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel

Serious events: 4 serious events

Other events: 13 other events

Deaths: 4 deaths

Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan

Serious events: 6 serious events

Other events: 13 other events

Deaths: 6 deaths

Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan

Serious events: 7 serious events

Other events: 41 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=8 participants at risk Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel n=14 participants at risk Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.	Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel n=13 participants at risk Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below: * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 participants at risk Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 participants at risk Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Cardiac disorders Tachycardia	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Colitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Chest pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Non-cardiac chest pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Pyrexia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Breast abscess	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Covid-19	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Neutropenic sepsis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Sepsis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Skin infection	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Vascular device infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood bilirubin increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Liver function test abnormal	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Lymphocyte count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Neutrophil count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations White blood cell count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Headache	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Presyncope	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Syncope	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Haematoma	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Hypotension	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Lymphoedema	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.

Other adverse events

Other adverse events
Measure	Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel n=8 participants at risk Participants received magrolimab intravenous (IV) infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 72 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 72 weeks. Participants did not receive paclitaxel in the Safety Run-in Cohort 1.	Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel n=14 participants at risk Participants received magrolimab IV infusion + nab-paclitaxel IV or paclitaxel IV as mentioned below in 28 days cycle: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, 22, Cycle 2 Days 1, 8, 15, 22 and Cycle 3 Days 1 and 15 onwards for every 28-day cycle for up to 70 weeks; * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 70 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 34 weeks.	Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel n=13 participants at risk Participants received nab-paclitaxel IV or paclitaxel IV as mentioned below: * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 54 weeks or paclitaxel 90 mg/m\^2 on Days 1, 8 and 15 of every 28-day cycle for up to 2.1 weeks.	Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan n=13 participants at risk Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 73 weeks.	Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan n=42 participants at risk Participants received magrolimab IV infusion + sacituzumab govitecan IV infusion as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, on Cycle 1 Days 8, 15, Cycle 2 Days 1, 8, and 15; 60 mg/kg, on Cycle 3 Day 1 onwards for every 21-day cycle for up to 48 weeks; * Sacituzumab govitecan 10 mg/kg on Days 1 and 8 onwards for every 21-day cycle for up to 49 weeks.
Blood and lymphatic system disorders Anaemia	87.5% 7/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	35.7% 5/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	84.6% 11/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	47.6% 20/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Haemolysis	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Neutropenia	25.0% 2/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	35.7% 5/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	53.8% 7/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.6% 12/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Red blood cell agglutination	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Cardiac disorders Atrial flutter	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Eye disorders Dry eye	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Eye disorders Eye pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Eye disorders Vision blurred	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	16.7% 7/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Constipation	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	40.5% 17/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Diarrhoea	37.5% 3/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	35.7% 5/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	84.6% 11/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	57.1% 24/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Dyspepsia	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	16.7% 7/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Flatulence	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Gastritis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	37.5% 3/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.6% 4/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	76.9% 10/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	71.4% 30/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Stomatitis	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.8% 10/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Toothache	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	62.5% 5/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Chest discomfort	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Chills	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 6/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Fatigue	37.5% 3/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	76.9% 10/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	52.4% 22/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Influenza like illness	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Malaise	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Non-cardiac chest pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Oedema	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Oedema peripheral	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Peripheral swelling	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Pyrexia	50.0% 4/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 6/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
General disorders Swelling face	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Hepatobiliary disorders Hyperbilirubinaemia	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Immune system disorders Seasonal allergy	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Bronchitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Catheter site infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Conjunctivitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Covid-19	25.0% 2/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Folliculitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Gastroenteritis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Gingivitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Herpes zoster	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Influenza	25.0% 2/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Laryngitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Nasopharyngitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Otitis media	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Pneumonia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Pseudomonas infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Rhinitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Sepsis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Sinusitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Viral infection	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Infections and infestations Wound infection	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Axillary web syndrome	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Infusion related reaction	25.0% 2/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Injury, poisoning and procedural complications Wound complication	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Alanine aminotransferase increased	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Aspartate aminotransferase increased	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Basophil count increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Bilirubin conjugated increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood bicarbonate decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood bilirubin increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood iron decreased	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood phosphorus decreased	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Blood urea increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations C-reactive protein increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Culture urine positive	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Gamma-glutamyltransferase increased	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Haptoglobin decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Lymphocyte count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Monocyte count increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Neutrophil count decreased	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	46.2% 6/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	38.1% 16/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Neutrophil count increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Platelet count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Prothrombin time prolonged	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Red blood cell count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Red cell distribution width increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Weight decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations Weight increased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Investigations White blood cell count decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	46.2% 6/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.6% 12/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypomagnesaemia	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	16.7% 7/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bone pain	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Joint swelling	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Akathisia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Aura	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Balance disorder	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Cerebral venous sinus thrombosis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Dizziness	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.6% 4/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	31.0% 13/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Dysgeusia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Headache	62.5% 5/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	42.9% 6/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	33.3% 14/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Hypoaesthesia	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Lethargy	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Neuropathy peripheral	37.5% 3/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Nystagmus	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Paraesthesia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.6% 4/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Nervous system disorders Syncope	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Product Issues Device occlusion	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Psychiatric disorders Anxiety	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Psychiatric disorders Confusional state	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Psychiatric disorders Depressed mood	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Psychiatric disorders Insomnia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Psychiatric disorders Libido decreased	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Renal and urinary disorders Cystitis noninfective	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Renal and urinary disorders Dysuria	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Renal and urinary disorders Urinary tract disorder	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Reproductive system and breast disorders Breast pain	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.8% 10/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.4% 3/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.8% 4/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	16.7% 7/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Emphysema	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.9% 5/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Alopecia	25.0% 2/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	35.7% 5/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	46.2% 6/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	26.2% 11/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Erythema	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Nail bed bleeding	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Nail bed tenderness	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	2.4% 1/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Onycholysis	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.6% 4/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	23.1% 3/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 6/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.5% 4/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.3% 2/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Haemorrhage	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 1/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Hot flush	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.8% 2/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Hypertension	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Hypotension	12.5% 1/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.4% 2/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Vascular disorders Lymphoedema	0.00% 0/8 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/14 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.7% 1/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/13 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.1% 3/42 • All-cause mortality: Up to 107 weeks; Adverse events: Up to 73 weeks plus 30 days All-cause Mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230

Email: [email protected]

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