Trial Outcomes & Findings for Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (NCT NCT04854499)

Last Updated: 2025-11-19

Results Overview

ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as determined by investigator assessment. CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

193 participants

Primary outcome timeframe

Up to 129 weeks

Results posted on

2025-11-19

Participant Flow

279 participants were screened.

Participants were enrolled at study sites in Europe, North America and Asia Pacific. Optional Phase 2 Cohort 2 was never opened due to closure of the study.

Participant milestones

Participant milestones
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Phase 2 Cohort 1 Arm A: Magrolimab + Pembrolizumab + Platinum + 5-FU Participants received magrolimab + pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 72 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 88 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 22 weeks for carboplatin and 23 weeks for cisplatin.	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU Participants received pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 70 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks for carboplatin and 18 weeks for cisplatin.	Phase 2 Cohort 1 Arm C: Magrolimab + Zimberelimab + Platinum + 5-FU Participants received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of every 21-day cycle for up to 40 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18 weeks for carboplatin and 16 weeks for cisplatin.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Overall Study STARTED	6	52	54	32	8	41
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	52	54	32	8	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Phase 2 Cohort 1 Arm A: Magrolimab + Pembrolizumab + Platinum + 5-FU Participants received magrolimab + pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 72 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 88 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 22 weeks for carboplatin and 23 weeks for cisplatin.	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU Participants received pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 70 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks for carboplatin and 18 weeks for cisplatin.	Phase 2 Cohort 1 Arm C: Magrolimab + Zimberelimab + Platinum + 5-FU Participants received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of every 21-day cycle for up to 40 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18 weeks for carboplatin and 16 weeks for cisplatin.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Overall Study Study Terminated by Sponsor	5	27	28	19	1	10
Overall Study Death	1	23	21	7	6	24
Overall Study Investigator's Discretion	0	1	3	4	1	5
Overall Study Withdrew Consent	0	1	2	2	0	1
Overall Study Lost to Follow-up	0	0	0	0	0	1

Baseline Characteristics

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=6 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Phase 2 Cohort 1 Arm A: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 72 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 88 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 22 weeks for carboplatin and 23 weeks for cisplatin.	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU n=54 Participants Participants received pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 70 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks for carboplatin and 18 weeks for cisplatin.	Phase 2 Cohort 1 Arm C: Magrolimab + Zimberelimab + Platinum + 5-FU n=32 Participants Participants received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of every 21-day cycle for up to 40 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18 weeks for carboplatin and 16 weeks for cisplatin.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=7 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=41 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants	0 Participants n=406 Participants	0 Participants n=2436 Participants
Age, Categorical Between 18 and 65 years	1 Participants	35 Participants n=4 Participants	33 Participants n=8 Participants	16 Participants n=19 Participants	5 Participants n=526 Participants	22 Participants n=406 Participants	112 Participants n=2436 Participants
Age, Categorical >=65 years	5 Participants	17 Participants n=4 Participants	21 Participants n=8 Participants	16 Participants n=19 Participants	2 Participants n=526 Participants	19 Participants n=406 Participants	80 Participants n=2436 Participants
Age, Continuous	69 years STANDARD_DEVIATION 6.2	61 years STANDARD_DEVIATION 7.4 • n=4 Participants	61 years STANDARD_DEVIATION 9.5 • n=8 Participants	63 years STANDARD_DEVIATION 11.4 • n=19 Participants	58 years STANDARD_DEVIATION 15.5 • n=526 Participants	63 years STANDARD_DEVIATION 9.9 • n=406 Participants	62 years STANDARD_DEVIATION 9.6 • n=2436 Participants
Sex: Female, Male Female	0 Participants	9 Participants n=4 Participants	11 Participants n=8 Participants	5 Participants n=19 Participants	0 Participants n=526 Participants	4 Participants n=406 Participants	29 Participants n=2436 Participants
Sex: Female, Male Male	6 Participants	43 Participants n=4 Participants	43 Participants n=8 Participants	27 Participants n=19 Participants	7 Participants n=526 Participants	37 Participants n=406 Participants	163 Participants n=2436 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	2 Participants n=4 Participants	0 Participants n=8 Participants	3 Participants n=19 Participants	1 Participants n=526 Participants	1 Participants n=406 Participants	7 Participants n=2436 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants	43 Participants n=4 Participants	44 Participants n=8 Participants	22 Participants n=19 Participants	6 Participants n=526 Participants	32 Participants n=406 Participants	153 Participants n=2436 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	7 Participants n=4 Participants	10 Participants n=8 Participants	7 Participants n=19 Participants	0 Participants n=526 Participants	8 Participants n=406 Participants	32 Participants n=2436 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants	0 Participants n=406 Participants	0 Participants n=2436 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants	2 Participants n=406 Participants	4 Participants n=2436 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants	0 Participants n=406 Participants	0 Participants n=2436 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants	0 Participants n=406 Participants	0 Participants n=2436 Participants
Race (NIH/OMB) White	5 Participants	44 Participants n=4 Participants	47 Participants n=8 Participants	26 Participants n=19 Participants	6 Participants n=526 Participants	30 Participants n=406 Participants	158 Participants n=2436 Participants
Race (NIH/OMB) More than one race	0 Participants	2 Participants n=4 Participants	1 Participants n=8 Participants	1 Participants n=19 Participants	1 Participants n=526 Participants	2 Participants n=406 Participants	7 Participants n=2436 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	6 Participants n=4 Participants	5 Participants n=8 Participants	5 Participants n=19 Participants	0 Participants n=526 Participants	7 Participants n=406 Participants	23 Participants n=2436 Participants
Region of Enrollment Belgium	0 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants	1 Participants n=19 Participants	0 Participants n=526 Participants	6 Participants n=406 Participants	15 Participants n=2436 Participants
Region of Enrollment United States	5 Participants	7 Participants n=4 Participants	8 Participants n=8 Participants	6 Participants n=19 Participants	5 Participants n=526 Participants	11 Participants n=406 Participants	42 Participants n=2436 Participants
Region of Enrollment Poland	0 Participants	9 Participants n=4 Participants	12 Participants n=8 Participants	7 Participants n=19 Participants	0 Participants n=526 Participants	1 Participants n=406 Participants	29 Participants n=2436 Participants
Region of Enrollment Italy	0 Participants	1 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants	1 Participants n=406 Participants	2 Participants n=2436 Participants
Region of Enrollment United Kingdom	0 Participants	3 Participants n=4 Participants	0 Participants n=8 Participants	2 Participants n=19 Participants	0 Participants n=526 Participants	0 Participants n=406 Participants	5 Participants n=2436 Participants
Region of Enrollment Australia	1 Participants	2 Participants n=4 Participants	7 Participants n=8 Participants	3 Participants n=19 Participants	2 Participants n=526 Participants	4 Participants n=406 Participants	19 Participants n=2436 Participants
Region of Enrollment France	0 Participants	7 Participants n=4 Participants	8 Participants n=8 Participants	9 Participants n=19 Participants	0 Participants n=526 Participants	10 Participants n=406 Participants	34 Participants n=2436 Participants
Region of Enrollment Portugal	0 Participants	15 Participants n=4 Participants	10 Participants n=8 Participants	1 Participants n=19 Participants	0 Participants n=526 Participants	1 Participants n=406 Participants	27 Participants n=2436 Participants
Region of Enrollment Germany	0 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants	2 Participants n=19 Participants	0 Participants n=526 Participants	3 Participants n=406 Participants	7 Participants n=2436 Participants
Region of Enrollment Spain	0 Participants	5 Participants n=4 Participants	2 Participants n=8 Participants	1 Participants n=19 Participants	0 Participants n=526 Participants	4 Participants n=406 Participants	12 Participants n=2436 Participants

PRIMARY outcome

Timeframe: First dose date up to 21 days

Population: DLT Evaluable Analysis Set was defined as all participants in the safety run-in evaluations who meet either of the following criteria during the DLT assessment period: The participants experienced a DLT at any time after initiation of the first infusion of magrolimab. The participant didn't experience a DLT and completed at least 2 infusions of magrolimab and at least 1 dose of pembrolizumab, platinum, and 5-FU for Safety Run-in Cohort 1; at least 1 dose of docetaxel for Safety Run-in Cohort 2.

A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the AE was related to magrolimab and the relationship of the AE with the combination partner regimen can be ruled out.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=6 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=6 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0	0 percentage of participants	0 percentage of participants	—	—	—	—

PRIMARY outcome

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

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

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point up to and including last dose date of study drug plus 30 days (or last dose date of zimberelimab plus 90 days) and prior to the day of initiation of subsequent anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=6 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=7 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities	83.3 percentage of participants	71.4 percentage of participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 1, Arms A and B in the ITT analysis set were analyzed.

PFS was defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by investigator assessment, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included 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. (Note: the appearance of one or more new lesions is also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=54 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)	5.5 months Interval 3.0 to 6.9	5.6 months Interval 4.2 to 7.4	—	—	—	—

PRIMARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 3 in the mITT Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=41 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohort 3: Objective Response Rate (ORR)	12.2 percentage of participants Interval 4.1 to 26.2	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 8 1-Hour Postdose; Days 15, 22, 43: Predose; Day 43 1-Hour Postdose; Day 71 1-Hour Postdose; Days 85,127, 190,197, 211, 253 Predose; Day 253 1-Hour Postdose

Population: Participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set, defined as all participants who received any amount of magrolimab and have at least 1 evaluable post-treatment serum concentration of magrolimab, at the given timepoint were analyzed. Per pre-specified plan, the PK analysis set included participants from Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=6 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=41 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=6 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=29 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 22 Predose	208 μg/mL Standard Deviation 185	250 μg/mL Standard Deviation 100	255 μg/mL Standard Deviation 149	253 μg/mL Standard Deviation 110	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 43 Predose	359 μg/mL Standard Deviation 253	397 μg/mL Standard Deviation 195	561 μg/mL Standard Deviation 514	477 μg/mL Standard Deviation 219	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 43 1-Hour Postdose	—	1440 μg/mL Standard Deviation 306	—	1330 μg/mL Standard Deviation 426	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 71 1-Hour Postdose	—	—	—	572 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 85 Predose	138 μg/mL Standard Deviation 106	308 μg/mL Standard Deviation 140	813 μg/mL Standard Deviation 830	272 μg/mL Standard Deviation 119	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 127 Predose	142 μg/mL Standard Deviation 113	204 μg/mL Standard Deviation 235	—	393 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 190 Predose	707 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	359 μg/mL Standard Deviation 94.9	NA μg/mL Standard Deviation 0 Data is not available as the concentrations were below the level of quantification.	270 μg/mL Standard Deviation 95.9	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 197 Predose	—	—	NA μg/mL Standard Deviation 0 Data is not available as the concentrations were below the level of quantification.	—	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 211 Predose	—	74.8 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	—	—	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 253 Predose	543 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	252 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	—	—	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 253 1-Hour Postdose	—	228 μg/mL Standard Deviation NA Standard Deviation cannot be calculated for one participant.	—	—	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 8 1-Hour Postdose	305 μg/mL Standard Deviation 56.4	481 μg/mL Standard Deviation 137	288 μg/mL Standard Deviation 55.2	459 μg/mL Standard Deviation 140	—	—
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab Day 15 Predose	—	149 μg/mL Standard Deviation 52.8	—	125 μg/mL Standard Deviation 49.4	—	—

SECONDARY outcome

Timeframe: Up to end of treatment (up to approximately 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 result.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=6 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=41 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=32 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=7 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=40 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab ADA Prevalence	16.7 percentage of participants	3.8 percentage of participants	—	—	0 percentage of participants	5.0 percentage of participants
Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab ADA Incidence	0 percentage of participants	0 percentage of participants	—	3.1 percentage of participants	0 percentage of participants	3.1 percentage of participants

SECONDARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 1 Arms B and C in the ITT Analysis Set were analyzed.

PFS was defined as the time from the date of randomization (Phase 2 Cohorts 1) or date of dose initiation (Phase 2 Cohorts 2 and 3) 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. Disease progression is defined in OM#2. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=54 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=32 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)	5.6 months Interval 4.2 to 7.4	5.5 months Interval 3.0 to 9.2	—	—	—	—

SECONDARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 1, Arms A, B and C in the ITT Analysis Set were analyzed.

ORR was defined as the percentage of participants who achieved a CR or PR as determined by investigator assessment. CR and PR are defined in OM#3.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=54 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=32 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)	38.5 percentage of participants Interval 25.3 to 53.0	38.9 percentage of participants Interval 25.9 to 53.1	37.5 percentage of participants Interval 21.1 to 56.3	—	—	—

SECONDARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 3 in the mITT Analysis Set were analyzed.

PFS was defined as the time from the date of dose initiation (Phase 2 Cohort 3) 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. Disease progression is defined in OM#2. KM estimates were used in outcome measure analysis

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=41 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohort 3: Progression-free Survival (PFS)	3.6 months Interval 2.4 to 4.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 1, Arms A, B and C in the ITT and participants in Phase 2 Cohort 3 in the mITT analysis set who achieved overall response were analyzed.

DOR was defined as the time from first documentation of CR or PR to the earliest date of documented disease progression or death from any cause, whichever occurs first. Disease progression is defined in OM#2 and CR and PR are defined in OM#3.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=20 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=21 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=12 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=5 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
All Phase 2 Cohorts: Duration of Response (DOR)	5.4 months Interval 3.5 to 9.3	6.2 months Interval 3.6 to Upper limit of CI was not estimable due to low number of participants with events.	6.3 months Interval 2.8 to Upper limit of CI was not estimable due to low number of participants with events.	5.0 months Interval 3.3 to Upper limit of CI was not estimable due to low number of participants with events.	—	—

SECONDARY outcome

Timeframe: Up to 129 weeks

Population: Participants in Phase 2 Cohort 1, Arms A, B and C in the ITT and participants in Phase 2 Cohort 3 in the mITT analysis set were analyzed.

OS was defined as the time from the date of randomization (Phase 2 Cohorts 1) or time from the date of dose initiation (Phase 2) to death from any cause. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=54 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=32 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=41 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
All Phase 2 Cohorts: Overall Survival (OS)	10.8 months Interval 6.9 to 18.2	13.3 months Interval 9.1 to Upper limit of CI was not estimable due to low number of participants with events.	NA months Interval 7.9 to Median and upper limit of CI were not estimable due to low number of participants with events.	9.1 months Interval 6.6 to 12.7	—	—

SECONDARY outcome

Timeframe: Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

Population: Phase 2 Cohort 1: Participants in the Intent to Treat Analysis Set with available data were analyzed. Phase 2 Cohort 3: Participants in the Modified Intent-to-Treat analysis set with available data were analyzed.

EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicated a higher level of symptoms (i.e. a worse state of the participant).

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=50 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=28 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=37 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 3	5.0 score on scale Standard Deviation 20.2	1.9 score on scale Standard Deviation 23.3	-3.6 score on scale Standard Deviation 16.1	1.7 score on scale Standard Deviation 18.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 6	6.0 score on scale Standard Deviation 26.5	10.2 score on scale Standard Deviation 26.7	-1.0 score on scale Standard Deviation 16.9	-1.3 score on scale Standard Deviation 23.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 9	2.8 score on scale Standard Deviation 22.2	1.1 score on scale Standard Deviation 27.6	-4.2 score on scale Standard Deviation 18.6	2.0 score on scale Standard Deviation 19.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 12	-4.8 score on scale Standard Deviation 29.2	6.4 score on scale Standard Deviation 25.8	2.9 score on scale Standard Deviation 14.1	-4.2 score on scale Standard Deviation 20.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 18	5.4 score on scale Standard Deviation 27.0	10.0 score on scale Standard Deviation 26.4	-4.5 score on scale Standard Deviation 23.1	-2.8 score on scale Standard Deviation 23.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 21	4.3 score on scale Standard Deviation 28.1	4.9 score on scale Standard Deviation 22.4	-10.8 score on scale Standard Deviation 23.6	-8.3 score on scale Standard Deviation 20.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Baseline	69.5 score on scale Standard Deviation 25.3	69.7 score on scale Standard Deviation 27.6	70.3 score on scale Standard Deviation 28.3	81.5 score on scale Standard Deviation 16.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 6	12.6 score on scale Standard Deviation 23.5	12.3 score on scale Standard Deviation 25.9	4.0 score on scale Standard Deviation 24.6	-5.7 score on scale Standard Deviation 21.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 6	2.1 score on scale Standard Deviation 15.7	0.9 score on scale Standard Deviation 25.8	-1.0 score on scale Standard Deviation 7.4	-2.6 score on scale Standard Deviation 24.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 18	-4.8 score on scale Standard Deviation 22.2	-1.3 score on scale Standard Deviation 20.9	-6.1 score on scale Standard Deviation 8.4	-3.3 score on scale Standard Deviation 16.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 21	-3.6 score on scale Standard Deviation 20.1	-0.7 score on scale Standard Deviation 18.7	-6.7 score on scale Standard Deviation 8.6	-10.3 score on scale Standard Deviation 26.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 6	3.6 score on scale Standard Deviation 27.7	6.9 score on scale Standard Deviation 33.4	-7.3 score on scale Standard Deviation 18.2	1.3 score on scale Standard Deviation 35.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 24	4.8 score on scale Standard Deviation 22.4	0.9 score on scale Standard Deviation 24.9	7.7 score on scale Standard Deviation 29.9	29.6 score on scale Standard Deviation 15.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 9	0.0 score on scale Standard Deviation 22.2	10.0 score on scale Standard Deviation 34.1	-5.3 score on scale Standard Deviation 20.1	11.1 score on scale Standard Deviation 21.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 15	10.8 score on scale Standard Deviation 29.0	3.4 score on scale Standard Deviation 32.5	5.1 score on scale Standard Deviation 26.7	13.0 score on scale Standard Deviation 25.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 18	4.6 score on scale Standard Deviation 21.3	7.7 score on scale Standard Deviation 30.3	9.1 score on scale Standard Deviation 15.6	24.4 score on scale Standard Deviation 29.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 21	5.6 score on scale Standard Deviation 21.2	16.7 score on scale Standard Deviation 32.6	11.1 score on scale Standard Deviation 35.8	20.5 score on scale Standard Deviation 29.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 27	2.1 score on scale Standard Deviation 14.8	4.4 score on scale Standard Deviation 24.8	6.7 score on scale Standard Deviation 14.9	13.3 score on scale Standard Deviation 38.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Baseline	39.1 score on scale Standard Deviation 27.0	34.7 score on scale Standard Deviation 30.1	34.5 score on scale Standard Deviation 35.7	34.2 score on scale Standard Deviation 33.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 3	-17.8 score on scale Standard Deviation 26.6	0.0 score on scale Standard Deviation 32.5	2.9 score on scale Standard Deviation 26.4	-2.3 score on scale Standard Deviation 23.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 6	-15.2 score on scale Standard Deviation 31.3	-11.1 score on scale Standard Deviation 39.0	14.6 score on scale Standard Deviation 32.1	1.3 score on scale Standard Deviation 31.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 9	-11.9 score on scale Standard Deviation 35.4	-20.0 score on scale Standard Deviation 38.8	-8.8 score on scale Standard Deviation 21.8	-9.5 score on scale Standard Deviation 23.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 15	-11.8 score on scale Standard Deviation 36.1	-13.8 score on scale Standard Deviation 33.9	-5.1 score on scale Standard Deviation 23.0	-7.4 score on scale Standard Deviation 31.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Baseline	29.5 score on scale Standard Deviation 37.7	20.7 score on scale Standard Deviation 24.2	29.6 score on scale Standard Deviation 31.1	32.4 score on scale Standard Deviation 36.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 6	-5.1 score on scale Standard Deviation 29.0	0.0 score on scale Standard Deviation 37.0	-4.2 score on scale Standard Deviation 16.7	-3.7 score on scale Standard Deviation 36.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 12	5.4 score on scale Standard Deviation 44.8	-1.0 score on scale Standard Deviation 32.8	-2.1 score on scale Standard Deviation 22.7	7.4 score on scale Standard Deviation 50.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 18	1.2 score on scale Standard Deviation 32.1	2.6 score on scale Standard Deviation 37.6	3.0 score on scale Standard Deviation 37.9	0.0 score on scale Standard Deviation 39.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 24	3.2 score on scale Standard Deviation 27.7	1.9 score on scale Standard Deviation 33.3	5.1 score on scale Standard Deviation 32.9	7.4 score on scale Standard Deviation 36.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 27	14.6 score on scale Standard Deviation 34.4	4.4 score on scale Standard Deviation 30.5	6.7 score on scale Standard Deviation 14.9	13.3 score on scale Standard Deviation 38.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Baseline	23.5 score on scale Standard Deviation 30.0	27.3 score on scale Standard Deviation 30.6	25.0 score on scale Standard Deviation 29.6	21.6 score on scale Standard Deviation 28.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 9	3.7 score on scale Standard Deviation 32.5	-2.2 score on scale Standard Deviation 38.1	-7.0 score on scale Standard Deviation 23.8	1.6 score on scale Standard Deviation 26.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 18	-7.1 score on scale Standard Deviation 31.9	-3.8 score on scale Standard Deviation 38.1	0.0 score on scale Standard Deviation 14.9	6.7 score on scale Standard Deviation 31.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 21	-7.2 score on scale Standard Deviation 31.7	1.4 score on scale Standard Deviation 39.9	-8.3 score on scale Standard Deviation 25.1	5.1 score on scale Standard Deviation 23.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 24	-10.0 score on scale Standard Deviation 40.6	1.9 score on scale Standard Deviation 47.8	-5.1 score on scale Standard Deviation 23.0	0.0 score on scale Standard Deviation 23.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 27	-6.7 score on scale Standard Deviation 42.2	4.4 score on scale Standard Deviation 41.5	-6.7 score on scale Standard Deviation 14.9	0.0 score on scale Standard Deviation 23.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Baseline	5.2 score on scale Standard Deviation 12.2	8.7 score on scale Standard Deviation 20.0	2.4 score on scale Standard Deviation 8.7	7.2 score on scale Standard Deviation 17.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 3	4.0 score on scale Standard Deviation 16.8	0.8 score on scale Standard Deviation 21.2	10.1 score on scale Standard Deviation 23.4	5.7 score on scale Standard Deviation 33.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 6	0.0 score on scale Standard Deviation 14.7	-1.9 score on scale Standard Deviation 17.7	4.2 score on scale Standard Deviation 11.4	3.8 score on scale Standard Deviation 35.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 9	6.2 score on scale Standard Deviation 26.2	-1.1 score on scale Standard Deviation 22.3	9.3 score on scale Standard Deviation 25.1	-1.6 score on scale Standard Deviation 19.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 12	4.3 score on scale Standard Deviation 20.6	0.0 score on scale Standard Deviation 18.6	5.9 score on scale Standard Deviation 13.1	7.4 score on scale Standard Deviation 21.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 15	8.9 score on scale Standard Deviation 26.2	-3.4 score on scale Standard Deviation 24.1	10.3 score on scale Standard Deviation 21.0	11.1 score on scale Standard Deviation 32.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 18	0.0 score on scale Standard Deviation 15.7	-4.0 score on scale Standard Deviation 20.0	6.1 score on scale Standard Deviation 13.5	11.1 score on scale Standard Deviation 24.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 21	0.0 score on scale Standard Deviation 10.1	4.2 score on scale Standard Deviation 22.7	6.7 score on scale Standard Deviation 14.1	17.9 score on scale Standard Deviation 22.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 24	1.7 score on scale Standard Deviation 13.1	-7.4 score on scale Standard Deviation 18.3	10.3 score on scale Standard Deviation 21.0	14.8 score on scale Standard Deviation 37.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 27	6.7 score on scale Standard Deviation 13.8	-4.4 score on scale Standard Deviation 27.8	11.1 score on scale Standard Deviation 17.2	13.3 score on scale Standard Deviation 38.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Baseline	16.3 score on scale Standard Deviation 26.1	22.2 score on scale Standard Deviation 32.5	17.9 score on scale Standard Deviation 29.4	14.7 score on scale Standard Deviation 29.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 3	-2.4 score on scale Standard Deviation 26.9	1.6 score on scale Standard Deviation 32.9	5.8 score on scale Standard Deviation 21.7	-2.6 score on scale Standard Deviation 20.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 6	-2.1 score on scale Standard Deviation 18.8	2.9 score on scale Standard Deviation 31.7	6.3 score on scale Standard Deviation 25.0	1.4 score on scale Standard Deviation 20.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 9	-1.2 score on scale Standard Deviation 29.9	3.4 score on scale Standard Deviation 25.7	-1.9 score on scale Standard Deviation 13.9	-7.0 score on scale Standard Deviation 30.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 12	3.2 score on scale Standard Deviation 32.6	8.1 score on scale Standard Deviation 28.9	0.0 score on scale Standard Deviation 16.7	6.3 score on scale Standard Deviation 32.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 15	8.9 score on scale Standard Deviation 30.2	1.2 score on scale Standard Deviation 32.1	-5.1 score on scale Standard Deviation 18.5	0.0 score on scale Standard Deviation 23.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 18	0.0 score on scale Standard Deviation 24.0	2.8 score on scale Standard Deviation 16.8	-3.0 score on scale Standard Deviation 10.1	-5.1 score on scale Standard Deviation 35.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 21	0.0 score on scale Standard Deviation 22.5	0.0 score on scale Standard Deviation 28.4	-3.3 score on scale Standard Deviation 10.5	-3.0 score on scale Standard Deviation 31.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 24	5.0 score on scale Standard Deviation 12.2	5.9 score on scale Standard Deviation 21.2	0.0 score on scale Standard Deviation 13.6	19.0 score on scale Standard Deviation 32.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 27	8.9 score on scale Standard Deviation 15.3	4.8 score on scale Standard Deviation 17.8	0.0 score on scale Standard Deviation 21.1	0.0 score on scale Standard Deviation 0.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Financial Difficulties: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Baseline	54.7 score on scale Standard Deviation 24.9	57.3 score on scale Standard Deviation 23.2	55.1 score on scale Standard Deviation 20.8	55.4 score on scale Standard Deviation 25.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 15	-0.3 score on scale Standard Deviation 27.0	5.2 score on scale Standard Deviation 25.8	2.6 score on scale Standard Deviation 22.7	0.0 score on scale Standard Deviation 24.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 24	9.2 score on scale Standard Deviation 26.3	1.9 score on scale Standard Deviation 20.9	-5.6 score on scale Standard Deviation 23.9	-10.2 score on scale Standard Deviation 15.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 27	2.2 score on scale Standard Deviation 27.7	0.0 score on scale Standard Deviation 18.6	6.9 score on scale Standard Deviation 26.0	1.7 score on scale Standard Deviation 24.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Global Health Status / QoL: Change from Baseline at Week 90	33.3 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Baseline	75.0 score on scale Standard Deviation 25.3	75.4 score on scale Standard Deviation 23.2	74.9 score on scale Standard Deviation 23.2	73.7 score on scale Standard Deviation 23.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 3	-4.8 score on scale Standard Deviation 15.6	-3.6 score on scale Standard Deviation 21.2	-9.2 score on scale Standard Deviation 15.7	-2.9 score on scale Standard Deviation 17.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 6	-3.4 score on scale Standard Deviation 14.4	2.2 score on scale Standard Deviation 20.2	-6.2 score on scale Standard Deviation 15.6	-11.3 score on scale Standard Deviation 21.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 9	-1.4 score on scale Standard Deviation 21.3	-1.0 score on scale Standard Deviation 18.8	-4.3 score on scale Standard Deviation 15.9	-2.9 score on scale Standard Deviation 13.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 12	-4.5 score on scale Standard Deviation 22.7	3.8 score on scale Standard Deviation 23.7	-5.3 score on scale Standard Deviation 15.7	-10.0 score on scale Standard Deviation 17.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 15	-6.5 score on scale Standard Deviation 21.0	3.3 score on scale Standard Deviation 26.2	-13.3 score on scale Standard Deviation 24.1	-11.9 score on scale Standard Deviation 19.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 18	0.0 score on scale Standard Deviation 15.5	2.7 score on scale Standard Deviation 27.7	-4.7 score on scale Standard Deviation 13.4	-16.0 score on scale Standard Deviation 20.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 21	-5.0 score on scale Standard Deviation 20.9	-6.5 score on scale Standard Deviation 21.4	-12.1 score on scale Standard Deviation 19.3	-21.0 score on scale Standard Deviation 24.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 24	-5.1 score on scale Standard Deviation 15.9	-7.4 score on scale Standard Deviation 23.6	-8.3 score on scale Standard Deviation 14.0	-21.5 score on scale Standard Deviation 10.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 27	-7.9 score on scale Standard Deviation 17.6	0.0 score on scale Standard Deviation 20.3	-12.0 score on scale Standard Deviation 14.5	-22.7 score on scale Standard Deviation 18.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Physical Functioning: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Baseline	72.8 score on scale Standard Deviation 32.5	74.5 score on scale Standard Deviation 27.7	69.8 score on scale Standard Deviation 32.0	60.8 score on scale Standard Deviation 35.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 3	-1.9 score on scale Standard Deviation 21.6	-2.4 score on scale Standard Deviation 33.9	-12.1 score on scale Standard Deviation 37.2	-5.7 score on scale Standard Deviation 28.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 6	-5.1 score on scale Standard Deviation 23.4	2.4 score on scale Standard Deviation 32.6	-10.0 score on scale Standard Deviation 19.7	-3.2 score on scale Standard Deviation 26.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 9	-3.6 score on scale Standard Deviation 29.2	-5.6 score on scale Standard Deviation 35.1	-9.3 score on scale Standard Deviation 30.4	7.9 score on scale Standard Deviation 27.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 12	-6.2 score on scale Standard Deviation 35.9	2.0 score on scale Standard Deviation 38.0	-7.3 score on scale Standard Deviation 33.3	-8.3 score on scale Standard Deviation 37.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 15	-10.4 score on scale Standard Deviation 36.4	7.5 score on scale Standard Deviation 35.8	-6.9 score on scale Standard Deviation 28.8	-4.6 score on scale Standard Deviation 32.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 18	-4.0 score on scale Standard Deviation 30.7	-1.3 score on scale Standard Deviation 37.1	-5.0 score on scale Standard Deviation 19.3	-7.8 score on scale Standard Deviation 37.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 21	-6.9 score on scale Standard Deviation 38.0	-11.6 score on scale Standard Deviation 29.1	-13.6 score on scale Standard Deviation 35.6	-14.1 score on scale Standard Deviation 39.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 24	-4.8 score on scale Standard Deviation 32.6	-2.8 score on scale Standard Deviation 30.9	0.0 score on scale Standard Deviation 24.6	-20.4 score on scale Standard Deviation 21.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 27	-16.7 score on scale Standard Deviation 21.1	-11.1 score on scale Standard Deviation 37.1	-10.0 score on scale Standard Deviation 22.4	-23.3 score on scale Standard Deviation 19.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Role Functioning: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 3	7.7 score on scale Standard Deviation 25.1	7.5 score on scale Standard Deviation 25.2	5.7 score on scale Standard Deviation 20.9	1.2 score on scale Standard Deviation 17.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 9	7.7 score on scale Standard Deviation 19.8	6.1 score on scale Standard Deviation 16.5	11.4 score on scale Standard Deviation 22.6	0.1 score on scale Standard Deviation 14.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 12	3.8 score on scale Standard Deviation 24.6	11.8 score on scale Standard Deviation 20.7	9.6 score on scale Standard Deviation 21.0	1.5 score on scale Standard Deviation 11.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 15	0.3 score on scale Standard Deviation 28.0	11.8 score on scale Standard Deviation 27.1	3.6 score on scale Standard Deviation 19.8	-5.4 score on scale Standard Deviation 19.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 18	3.7 score on scale Standard Deviation 23.8	12.0 score on scale Standard Deviation 25.8	6.6 score on scale Standard Deviation 28.6	-4.4 score on scale Standard Deviation 16.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 21	0.8 score on scale Standard Deviation 22.6	2.0 score on scale Standard Deviation 22.5	6.7 score on scale Standard Deviation 12.3	-5.6 score on scale Standard Deviation 12.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 24	3.1 score on scale Standard Deviation 20.0	4.6 score on scale Standard Deviation 22.4	2.4 score on scale Standard Deviation 19.8	-4.3 score on scale Standard Deviation 9.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 27	0.6 score on scale Standard Deviation 16.5	9.6 score on scale Standard Deviation 10.9	6.5 score on scale Standard Deviation 27.6	-11.1 score on scale Standard Deviation 18.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales: Emotional Functioning: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Baseline	84.0 score on scale Standard Deviation 22.1	84.7 score on scale Standard Deviation 22.3	85.7 score on scale Standard Deviation 16.8	83.8 score on scale Standard Deviation 21.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 3	1.6 score on scale Standard Deviation 16.0	-0.4 score on scale Standard Deviation 20.7	-7.2 score on scale Standard Deviation 14.1	-4.6 score on scale Standard Deviation 16.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 9	1.9 score on scale Standard Deviation 14.1	-0.6 score on scale Standard Deviation 14.8	-2.8 score on scale Standard Deviation 13.1	-4.8 score on scale Standard Deviation 19.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 12	-6.5 score on scale Standard Deviation 23.8	1.5 score on scale Standard Deviation 18.5	-4.9 score on scale Standard Deviation 12.9	-3.7 score on scale Standard Deviation 20.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 15	-3.8 score on scale Standard Deviation 22.2	0.6 score on scale Standard Deviation 19.1	-1.3 score on scale Standard Deviation 12.7	-1.9 score on scale Standard Deviation 13.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 24	-3.3 score on scale Standard Deviation 16.8	-3.7 score on scale Standard Deviation 18.6	-3.8 score on scale Standard Deviation 12.1	-13.0 score on scale Standard Deviation 16.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 27	0.0 score on scale Standard Deviation 15.4	-4.4 score on scale Standard Deviation 11.7	-5.6 score on scale Standard Deviation 8.6	-33.3 score on scale Standard Deviation 31.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Cognitive Functioning : Change from Baseline at Week 90	16.7 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Baseline	75.5 score on scale Standard Deviation 26.5	73.8 score on scale Standard Deviation 31.2	76.8 score on scale Standard Deviation 24.1	68.0 score on scale Standard Deviation 36.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 3	2.4 score on scale Standard Deviation 24.6	-3.5 score on scale Standard Deviation 33.6	-12.3 score on scale Standard Deviation 23.7	-3.4 score on scale Standard Deviation 30.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 9	-3.7 score on scale Standard Deviation 28.6	-3.3 score on scale Standard Deviation 23.3	-7.4 score on scale Standard Deviation 21.6	9.5 score on scale Standard Deviation 34.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 12	-2.2 score on scale Standard Deviation 30.0	0.5 score on scale Standard Deviation 31.0	-4.9 score on scale Standard Deviation 19.3	-7.4 score on scale Standard Deviation 27.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 15	-8.1 score on scale Standard Deviation 34.1	4.0 score on scale Standard Deviation 27.7	5.1 score on scale Standard Deviation 23.0	-2.8 score on scale Standard Deviation 41.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 18	1.2 score on scale Standard Deviation 22.6	2.7 score on scale Standard Deviation 19.6	-1.5 score on scale Standard Deviation 15.7	7.8 score on scale Standard Deviation 36.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 21	-5.8 score on scale Standard Deviation 30.0	-0.7 score on scale Standard Deviation 24.3	-11.7 score on scale Standard Deviation 28.4	-5.1 score on scale Standard Deviation 41.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 24	-0.8 score on scale Standard Deviation 28.9	-4.6 score on scale Standard Deviation 32.7	-1.3 score on scale Standard Deviation 22.0	-22.2 score on scale Standard Deviation 25.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 27	-2.2 score on scale Standard Deviation 30.8	-5.6 score on scale Standard Deviation 12.1	-5.6 score on scale Standard Deviation 13.6	-33.3 score on scale Standard Deviation 31.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Functional Scales : Social Functioning : Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Baseline	37.4 score on scale Standard Deviation 28.9	38.6 score on scale Standard Deviation 24.3	40.1 score on scale Standard Deviation 30.3	42.9 score on scale Standard Deviation 29.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 3	1.7 score on scale Standard Deviation 19.7	2.5 score on scale Standard Deviation 20.8	7.2 score on scale Standard Deviation 26.7	8.0 score on scale Standard Deviation 25.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 6	-2.7 score on scale Standard Deviation 21.9	-5.4 score on scale Standard Deviation 27.3	4.2 score on scale Standard Deviation 27.5	13.2 score on scale Standard Deviation 28.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 9	0.4 score on scale Standard Deviation 22.5	-0.2 score on scale Standard Deviation 31.2	3.8 score on scale Standard Deviation 29.5	-3.2 score on scale Standard Deviation 26.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 12	2.8 score on scale Standard Deviation 24.1	-4.4 score on scale Standard Deviation 26.9	2.0 score on scale Standard Deviation 26.1	8.6 score on scale Standard Deviation 27.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 15	8.6 score on scale Standard Deviation 28.4	-4.4 score on scale Standard Deviation 27.5	8.5 score on scale Standard Deviation 36.6	12.3 score on scale Standard Deviation 24.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 18	4.2 score on scale Standard Deviation 23.8	-2.6 score on scale Standard Deviation 25.5	7.1 score on scale Standard Deviation 36.6	18.5 score on scale Standard Deviation 31.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 21	3.7 score on scale Standard Deviation 27.3	2.5 score on scale Standard Deviation 23.9	11.6 score on scale Standard Deviation 40.2	15.4 score on scale Standard Deviation 30.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 27	2.1 score on scale Standard Deviation 17.8	4.8 score on scale Standard Deviation 27.8	2.2 score on scale Standard Deviation 25.3	35.6 score on scale Standard Deviation 24.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Fatigue: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Baseline	5.6 score on scale Standard Deviation 16.6	5.7 score on scale Standard Deviation 12.4	4.8 score on scale Standard Deviation 11.9	7.7 score on scale Standard Deviation 15.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 3	6.7 score on scale Standard Deviation 20.2	5.0 score on scale Standard Deviation 16.5	15.9 score on scale Standard Deviation 34.3	2.9 score on scale Standard Deviation 12.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 6	1.0 score on scale Standard Deviation 13.8	2.3 score on scale Standard Deviation 21.1	2.1 score on scale Standard Deviation 16.0	0.6 score on scale Standard Deviation 16.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 9	8.6 score on scale Standard Deviation 25.1	3.9 score on scale Standard Deviation 20.4	7.9 score on scale Standard Deviation 25.1	5.6 score on scale Standard Deviation 21.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 12	13.3 score on scale Standard Deviation 27.5	3.9 score on scale Standard Deviation 18.8	1.0 score on scale Standard Deviation 23.9	-1.9 score on scale Standard Deviation 13.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 15	5.9 score on scale Standard Deviation 21.8	5.7 score on scale Standard Deviation 22.8	5.1 score on scale Standard Deviation 12.5	3.7 score on scale Standard Deviation 18.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 18	3.6 score on scale Standard Deviation 18.9	4.5 score on scale Standard Deviation 21.9	3.0 score on scale Standard Deviation 10.1	5.6 score on scale Standard Deviation 26.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 21	7.6 score on scale Standard Deviation 18.4	6.3 score on scale Standard Deviation 21.3	11.1 score on scale Standard Deviation 29.6	7.7 score on scale Standard Deviation 20.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 24	4.8 score on scale Standard Deviation 12.0	0.0 score on scale Standard Deviation 9.9	5.1 score on scale Standard Deviation 12.5	-1.9 score on scale Standard Deviation 13.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 27	2.1 score on scale Standard Deviation 12.0	4.4 score on scale Standard Deviation 13.3	13.3 score on scale Standard Deviation 18.3	-3.3 score on scale Standard Deviation 18.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Nausea and Vomiting : Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Baseline	37.2 score on scale Standard Deviation 32.1	40.3 score on scale Standard Deviation 30.9	39.9 score on scale Standard Deviation 31.5	36.0 score on scale Standard Deviation 33.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 3	-5.8 score on scale Standard Deviation 27.4	-3.9 score on scale Standard Deviation 31.0	-2.9 score on scale Standard Deviation 25.5	-5.7 score on scale Standard Deviation 27.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 6	-12.1 score on scale Standard Deviation 22.5	-19.9 score on scale Standard Deviation 36.0	-10.4 score on scale Standard Deviation 22.7	-3.7 score on scale Standard Deviation 34.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 9	-7.7 score on scale Standard Deviation 23.8	-13.9 score on scale Standard Deviation 29.1	-8.8 score on scale Standard Deviation 28.5	-13.5 score on scale Standard Deviation 28.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 12	-4.7 score on scale Standard Deviation 28.5	-23.0 score on scale Standard Deviation 34.6	-13.7 score on scale Standard Deviation 24.5	-3.7 score on scale Standard Deviation 31.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 15	-2.6 score on scale Standard Deviation 31.4	-19.0 score on scale Standard Deviation 36.4	0.0 score on scale Standard Deviation 30.4	-4.6 score on scale Standard Deviation 34.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 18	-8.0 score on scale Standard Deviation 22.5	-18.6 score on scale Standard Deviation 35.4	6.1 score on scale Standard Deviation 15.4	-2.2 score on scale Standard Deviation 30.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 21	-1.4 score on scale Standard Deviation 28.6	-10.4 score on scale Standard Deviation 31.8	-1.4 score on scale Standard Deviation 35.9	-6.4 score on scale Standard Deviation 35.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 24	-0.8 score on scale Standard Deviation 22.0	-12.0 score on scale Standard Deviation 29.6	0.0 score on scale Standard Deviation 31.2	9.3 score on scale Standard Deviation 16.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 27	9.4 score on scale Standard Deviation 28.5	-8.9 score on scale Standard Deviation 39.3	8.3 score on scale Standard Deviation 17.5	16.7 score on scale Standard Deviation 39.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Pain : Change from Baseline at Week 90	-16.7 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Baseline	17.0 score on scale Standard Deviation 25.3	15.3 score on scale Standard Deviation 24.5	22.6 score on scale Standard Deviation 31.5	24.3 score on scale Standard Deviation 32.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 3	0.8 score on scale Standard Deviation 20.1	2.3 score on scale Standard Deviation 28.5	1.4 score on scale Standard Deviation 18.7	9.2 score on scale Standard Deviation 23.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 6	2.1 score on scale Standard Deviation 20.6	-1.9 score on scale Standard Deviation 27.9	6.3 score on scale Standard Deviation 18.1	13.6 score on scale Standard Deviation 34.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 12	3.1 score on scale Standard Deviation 23.0	5.9 score on scale Standard Deviation 32.3	3.9 score on scale Standard Deviation 20.0	0.0 score on scale Standard Deviation 19.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Dyspnoea : Change from Baseline at Week 24	1.6 score on scale Standard Deviation 22.3	5.6 score on scale Standard Deviation 32.8	7.7 score on scale Standard Deviation 24.2	11.1 score on scale Standard Deviation 28.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 12	-15.6 score on scale Standard Deviation 40.6	-16.7 score on scale Standard Deviation 34.1	-7.8 score on scale Standard Deviation 30.1	-3.7 score on scale Standard Deviation 25.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 18	-11.5 score on scale Standard Deviation 27.1	-7.7 score on scale Standard Deviation 40.3	-3.0 score on scale Standard Deviation 37.9	6.7 score on scale Standard Deviation 28.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 21	-2.8 score on scale Standard Deviation 27.7	-6.9 score on scale Standard Deviation 42.8	-2.8 score on scale Standard Deviation 17.2	-2.6 score on scale Standard Deviation 41.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 24	-4.8 score on scale Standard Deviation 30.3	-11.1 score on scale Standard Deviation 37.9	-10.3 score on scale Standard Deviation 34.4	11.1 score on scale Standard Deviation 33.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 27	0.0 score on scale Standard Deviation 36.5	2.2 score on scale Standard Deviation 44.5	6.7 score on scale Standard Deviation 27.9	13.3 score on scale Standard Deviation 50.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Insomnia : Change from Baseline at Week 90	-33.3 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 3	6.2 score on scale Standard Deviation 29.3	7.0 score on scale Standard Deviation 27.8	13.6 score on scale Standard Deviation 33.6	2.4 score on scale Standard Deviation 33.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 9	3.6 score on scale Standard Deviation 36.7	2.2 score on scale Standard Deviation 38.1	1.9 score on scale Standard Deviation 37.0	-4.8 score on scale Standard Deviation 33.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 15	6.5 score on scale Standard Deviation 37.9	2.3 score on scale Standard Deviation 36.7	8.3 score on scale Standard Deviation 28.9	5.9 score on scale Standard Deviation 29.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Appetite Loss: Change from Baseline at Week 21	6.9 score on scale Standard Deviation 42.8	9.7 score on scale Standard Deviation 39.9	13.9 score on scale Standard Deviation 38.8	2.6 score on scale Standard Deviation 39.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 3	0.8 score on scale Standard Deviation 23.8	-3.1 score on scale Standard Deviation 33.2	5.8 score on scale Standard Deviation 32.8	2.3 score on scale Standard Deviation 21.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 6	-6.3 score on scale Standard Deviation 33.3	-1.9 score on scale Standard Deviation 33.8	0.0 score on scale Standard Deviation 32.2	0.0 score on scale Standard Deviation 20.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 12	-2.2 score on scale Standard Deviation 36.0	-1.0 score on scale Standard Deviation 32.3	-2.0 score on scale Standard Deviation 27.6	3.7 score on scale Standard Deviation 27.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 15	-2.2 score on scale Standard Deviation 31.0	-2.3 score on scale Standard Deviation 39.8	0.0 score on scale Standard Deviation 36.0	11.1 score on scale Standard Deviation 36.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Constipation: Change from Baseline at Week 90	-33.3 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) Score Symptom Scales / Items: Diarrhoea: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA Standard deviation cannot be calculated for one participant.	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27, and Week 90

Population: Phase 2 Cohort 1: Participants in the Intent-to-Treat Analysis Set with available data were analyzed. Phase 2 Cohort 3: Participants in the Modified Intent-to-Treat Analysis Set with available data were analyzed.

The H\&N35 is a 35-item questionnaire for participants with H\&N cancer. It includes 7 multi-item scales that assess pain (4 items), swallowing (4 items), senses (2 items), speech (3 items), social eating (4 items), social contact (5 items), and sexuality (2 items). There are also 11 single items: teeth, opening mouth, dry mouth, sticky saliva, coughing, felt ill, pain killers, nutritional supplements, feeding tube, weight loss, weight gain. All symptoms scales, scores were transformed in range of 0 to 100, where higher scores indicated more severe symptoms. A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=49 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=28 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=37 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 3	-2.8 score on scale Standard Deviation 27.3	3.0 score on scale Standard Deviation 22.8	6.0 score on scale Standard Deviation 15.3	-5.7 score on scale Standard Deviation 21.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 6	-4.7 score on scale Standard Deviation 22.7	-2.9 score on scale Standard Deviation 31.8	0.0 score on scale Standard Deviation 23.6	-4.6 score on scale Standard Deviation 23.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 9	-2.1 score on scale Standard Deviation 24.5	-3.2 score on scale Standard Deviation 22.4	2.3 score on scale Standard Deviation 33.1	-6.0 score on scale Standard Deviation 29.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Baseline	27.1 score on scale Standard Deviation 30.6	26.7 score on scale Standard Deviation 24.8	28.7 score on scale Standard Deviation 25.2	25.0 score on scale Standard Deviation 25.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 12	-5.2 score on scale Standard Deviation 24.7	-7.9 score on scale Standard Deviation 29.1	-4.6 score on scale Standard Deviation 26.5	3.9 score on scale Standard Deviation 21.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 15	2.4 score on scale Standard Deviation 25.6	-5.7 score on scale Standard Deviation 30.6	-5.8 score on scale Standard Deviation 24.9	-7.4 score on scale Standard Deviation 28.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 18	-2.1 score on scale Standard Deviation 21.7	-10.3 score on scale Standard Deviation 29.1	6.8 score on scale Standard Deviation 16.2	-1.2 score on scale Standard Deviation 15.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 21	2.1 score on scale Standard Deviation 27.6	-1.7 score on scale Standard Deviation 34.6	-6.8 score on scale Standard Deviation 19.3	-4.5 score on scale Standard Deviation 31.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 24	-3.6 score on scale Standard Deviation 21.8	-11.8 score on scale Standard Deviation 37.6	-4.5 score on scale Standard Deviation 15.1	2.2 score on scale Standard Deviation 24.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 27	-4.2 score on scale Standard Deviation 24.7	-10.6 score on scale Standard Deviation 36.1	-6.9 score on scale Standard Deviation 24.4	5.0 score on scale Standard Deviation 22.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items : Pain; Change from Baseline at Week 90	-58.3 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Baseline	30.1 score on scale Standard Deviation 33.2	33.6 score on scale Standard Deviation 34.8	31.0 score on scale Standard Deviation 26.1	36.3 score on scale Standard Deviation 31.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 3	-4.3 score on scale Standard Deviation 24.6	2.3 score on scale Standard Deviation 24.5	4.1 score on scale Standard Deviation 21.3	-3.4 score on scale Standard Deviation 20.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 6	-9.7 score on scale Standard Deviation 22.5	-8.3 score on scale Standard Deviation 29.7	-3.1 score on scale Standard Deviation 22.1	-7.7 score on scale Standard Deviation 24.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 9	-5.9 score on scale Standard Deviation 24.0	-6.6 score on scale Standard Deviation 24.9	0.4 score on scale Standard Deviation 25.5	-9.0 score on scale Standard Deviation 31.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 12	-6.9 score on scale Standard Deviation 25.0	-3.3 score on scale Standard Deviation 21.5	-5.4 score on scale Standard Deviation 15.9	-3.5 score on scale Standard Deviation 20.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 15	-3.0 score on scale Standard Deviation 29.2	-0.3 score on scale Standard Deviation 23.0	-8.3 score on scale Standard Deviation 19.2	-8.3 score on scale Standard Deviation 23.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 18	-5.1 score on scale Standard Deviation 28.9	0.0 score on scale Standard Deviation 32.8	-2.3 score on scale Standard Deviation 10.6	-3.6 score on scale Standard Deviation 15.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 21	-2.2 score on scale Standard Deviation 25.0	5.7 score on scale Standard Deviation 33.3	-3.8 score on scale Standard Deviation 13.6	-15.0 score on scale Standard Deviation 29.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 24	-3.3 score on scale Standard Deviation 23.0	-1.0 score on scale Standard Deviation 18.1	-2.6 score on scale Standard Deviation 18.4	0.0 score on scale Standard Deviation 20.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 27	5.7 score on scale Standard Deviation 22.7	-5.6 score on scale Standard Deviation 21.1	-13.9 score on scale Standard Deviation 11.4	-1.7 score on scale Standard Deviation 12.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Swallowing; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Baseline	16.0 score on scale Standard Deviation 25.8	23.5 score on scale Standard Deviation 30.6	18.5 score on scale Standard Deviation 26.2	29.2 score on scale Standard Deviation 29.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 3	-0.4 score on scale Standard Deviation 21.0	-1.2 score on scale Standard Deviation 21.3	0.7 score on scale Standard Deviation 19.8	-4.0 score on scale Standard Deviation 25.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 6	-4.2 score on scale Standard Deviation 21.2	2.8 score on scale Standard Deviation 30.5	9.4 score on scale Standard Deviation 14.9	1.9 score on scale Standard Deviation 22.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 9	-3.6 score on scale Standard Deviation 21.4	0.6 score on scale Standard Deviation 22.9	3.5 score on scale Standard Deviation 28.1	0.8 score on scale Standard Deviation 18.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 21	3.5 score on scale Standard Deviation 26.5	4.9 score on scale Standard Deviation 31.3	1.5 score on scale Standard Deviation 13.9	-1.3 score on scale Standard Deviation 19.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 24	2.4 score on scale Standard Deviation 29.0	3.9 score on scale Standard Deviation 25.4	-1.3 score on scale Standard Deviation 12.7	-3.7 score on scale Standard Deviation 27.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 27	8.3 score on scale Standard Deviation 40.4	-2.2 score on scale Standard Deviation 17.7	-5.6 score on scale Standard Deviation 13.6	13.3 score on scale Standard Deviation 13.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Baseline	36.2 score on scale Standard Deviation 32.7	32.1 score on scale Standard Deviation 31.0	32.1 score on scale Standard Deviation 27.8	29.3 score on scale Standard Deviation 30.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 3	-6.7 score on scale Standard Deviation 22.2	-1.1 score on scale Standard Deviation 19.9	0.5 score on scale Standard Deviation 19.1	4.2 score on scale Standard Deviation 26.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 6	-11.9 score on scale Standard Deviation 21.4	-6.3 score on scale Standard Deviation 29.6	-2.1 score on scale Standard Deviation 20.8	-1.3 score on scale Standard Deviation 27.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 9	-9.0 score on scale Standard Deviation 27.9	1.0 score on scale Standard Deviation 20.6	4.7 score on scale Standard Deviation 20.7	-1.7 score on scale Standard Deviation 22.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 12	-10.7 score on scale Standard Deviation 23.5	-7.4 score on scale Standard Deviation 22.0	-7.2 score on scale Standard Deviation 21.1	4.3 score on scale Standard Deviation 19.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 15	-3.8 score on scale Standard Deviation 27.7	-0.6 score on scale Standard Deviation 22.0	-12.8 score on scale Standard Deviation 14.9	4.6 score on scale Standard Deviation 24.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 18	-7.0 score on scale Standard Deviation 24.1	-8.3 score on scale Standard Deviation 19.2	-4.0 score on scale Standard Deviation 13.4	5.6 score on scale Standard Deviation 19.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 21	-3.5 score on scale Standard Deviation 20.7	3.0 score on scale Standard Deviation 18.9	-5.1 score on scale Standard Deviation 18.0	6.5 score on scale Standard Deviation 30.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 24	-10.5 score on scale Standard Deviation 20.1	0.7 score on scale Standard Deviation 17.3	-7.7 score on scale Standard Deviation 16.0	4.2 score on scale Standard Deviation 22.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 27	-6.3 score on scale Standard Deviation 24.2	-1.9 score on scale Standard Deviation 17.3	-9.3 score on scale Standard Deviation 14.8	22.2 score on scale Standard Deviation 24.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Baseline	33.8 score on scale Standard Deviation 32.8	34.2 score on scale Standard Deviation 28.5	28.3 score on scale Standard Deviation 26.7	24.8 score on scale Standard Deviation 26.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 3	0.7 score on scale Standard Deviation 31.5	0.2 score on scale Standard Deviation 24.8	7.4 score on scale Standard Deviation 20.0	3.9 score on scale Standard Deviation 14.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 6	-9.2 score on scale Standard Deviation 18.0	-6.9 score on scale Standard Deviation 33.0	3.0 score on scale Standard Deviation 16.8	2.4 score on scale Standard Deviation 25.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 9	-8.2 score on scale Standard Deviation 23.9	1.2 score on scale Standard Deviation 24.4	4.4 score on scale Standard Deviation 28.8	-3.6 score on scale Standard Deviation 17.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 12	-4.9 score on scale Standard Deviation 27.5	-9.4 score on scale Standard Deviation 24.2	2.5 score on scale Standard Deviation 24.2	6.1 score on scale Standard Deviation 15.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 15	-3.0 score on scale Standard Deviation 23.3	-1.4 score on scale Standard Deviation 32.9	-3.4 score on scale Standard Deviation 22.5	8.3 score on scale Standard Deviation 20.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 18	-9.2 score on scale Standard Deviation 21.4	0.0 score on scale Standard Deviation 30.8	3.5 score on scale Standard Deviation 25.2	6.1 score on scale Standard Deviation 24.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 21	-8.0 score on scale Standard Deviation 27.7	7.6 score on scale Standard Deviation 28.7	4.6 score on scale Standard Deviation 23.8	-3.8 score on scale Standard Deviation 20.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 24	-17.1 score on scale Standard Deviation 24.0	-1.0 score on scale Standard Deviation 20.4	1.7 score on scale Standard Deviation 26.7	9.9 score on scale Standard Deviation 23.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 27	-3.6 score on scale Standard Deviation 24.8	-1.2 score on scale Standard Deviation 13.8	0.5 score on scale Standard Deviation 16.3	20.0 score on scale Standard Deviation 19.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Eating; Change from Baseline at Week 90	-8.3 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Baseline	21.4 score on scale Standard Deviation 24.6	21.7 score on scale Standard Deviation 28.0	15.5 score on scale Standard Deviation 22.2	13.4 score on scale Standard Deviation 19.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 3	-3.5 score on scale Standard Deviation 24.4	5.4 score on scale Standard Deviation 21.6	5.2 score on scale Standard Deviation 19.9	6.9 score on scale Standard Deviation 15.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 6	-9.2 score on scale Standard Deviation 13.9	-2.7 score on scale Standard Deviation 28.1	2.9 score on scale Standard Deviation 22.4	10.0 score on scale Standard Deviation 21.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 9	-8.0 score on scale Standard Deviation 17.6	1.4 score on scale Standard Deviation 18.5	6.8 score on scale Standard Deviation 24.8	-0.6 score on scale Standard Deviation 11.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 12	-1.7 score on scale Standard Deviation 18.0	-5.4 score on scale Standard Deviation 22.4	-2.8 score on scale Standard Deviation 19.0	2.5 score on scale Standard Deviation 20.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 15	1.4 score on scale Standard Deviation 28.6	-2.1 score on scale Standard Deviation 24.0	-5.1 score on scale Standard Deviation 15.7	7.0 score on scale Standard Deviation 19.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 18	-1.8 score on scale Standard Deviation 24.6	-1.6 score on scale Standard Deviation 22.2	-2.4 score on scale Standard Deviation 18.7	0.4 score on scale Standard Deviation 15.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 21	-1.9 score on scale Standard Deviation 26.9	9.3 score on scale Standard Deviation 18.0	-2.2 score on scale Standard Deviation 20.4	9.2 score on scale Standard Deviation 23.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 24	-5.1 score on scale Standard Deviation 22.3	2.7 score on scale Standard Deviation 11.6	0.5 score on scale Standard Deviation 23.2	5.2 score on scale Standard Deviation 9.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 27	-4.3 score on scale Standard Deviation 25.8	-0.9 score on scale Standard Deviation 19.5	-4.4 score on scale Standard Deviation 15.6	17.3 score on scale Standard Deviation 28.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Trouble with Social Contact; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Baseline	34.0 score on scale Standard Deviation 34.8	38.9 score on scale Standard Deviation 41.0	30.9 score on scale Standard Deviation 29.1	40.2 score on scale Standard Deviation 37.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 3	4.3 score on scale Standard Deviation 23.5	7.4 score on scale Standard Deviation 37.9	9.5 score on scale Standard Deviation 38.6	4.5 score on scale Standard Deviation 23.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 6	4.2 score on scale Standard Deviation 28.9	16.1 score on scale Standard Deviation 43.3	3.6 score on scale Standard Deviation 39.9	-3.6 score on scale Standard Deviation 32.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 9	7.1 score on scale Standard Deviation 42.2	5.1 score on scale Standard Deviation 39.4	18.7 score on scale Standard Deviation 43.4	1.8 score on scale Standard Deviation 31.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 12	0.6 score on scale Standard Deviation 32.2	5.4 score on scale Standard Deviation 36.3	22.2 score on scale Standard Deviation 40.7	2.9 score on scale Standard Deviation 30.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 15	9.5 score on scale Standard Deviation 43.4	9.0 score on scale Standard Deviation 42.3	2.8 score on scale Standard Deviation 48.6	2.1 score on scale Standard Deviation 30.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 18	-3.2 score on scale Standard Deviation 33.7	2.5 score on scale Standard Deviation 39.5	5.6 score on scale Standard Deviation 39.1	-5.6 score on scale Standard Deviation 32.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 21	-2.9 score on scale Standard Deviation 42.8	0.8 score on scale Standard Deviation 39.2	21.7 score on scale Standard Deviation 36.9	3.0 score on scale Standard Deviation 38.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 24	-0.9 score on scale Standard Deviation 23.9	7.7 score on scale Standard Deviation 47.4	11.7 score on scale Standard Deviation 27.3	-9.5 score on scale Standard Deviation 41.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 27	9.0 score on scale Standard Deviation 23.2	6.9 score on scale Standard Deviation 47.9	-25.0 score on scale Standard Deviation 50.0	-33.3 score on scale Standard Deviation 57.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Less Sexuality; Change from Baseline at Week 90	-33.3 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Baseline	21.3 score on scale Standard Deviation 33.5	16.7 score on scale Standard Deviation 28.8	14.3 score on scale Standard Deviation 32.0	30.6 score on scale Standard Deviation 37.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 3	-11.4 score on scale Standard Deviation 36.2	-0.9 score on scale Standard Deviation 26.3	7.2 score on scale Standard Deviation 24.5	-11.5 score on scale Standard Deviation 27.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 9	6.0 score on scale Standard Deviation 28.8	-2.5 score on scale Standard Deviation 22.5	-1.8 score on scale Standard Deviation 36.0	-17.5 score on scale Standard Deviation 34.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 12	6.7 score on scale Standard Deviation 34.4	1.1 score on scale Standard Deviation 33.9	5.9 score on scale Standard Deviation 29.4	-8.8 score on scale Standard Deviation 38.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 15	0.0 score on scale Standard Deviation 31.6	5.3 score on scale Standard Deviation 39.3	-12.8 score on scale Standard Deviation 29.0	-9.3 score on scale Standard Deviation 35.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 27	2.4 score on scale Standard Deviation 24.3	-6.1 score on scale Standard Deviation 13.5	0.0 score on scale Standard Deviation 21.1	-20.0 score on scale Standard Deviation 50.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Baseline	32.7 score on scale Standard Deviation 40.7	39.6 score on scale Standard Deviation 41.1	22.6 score on scale Standard Deviation 32.8	37.8 score on scale Standard Deviation 41.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 9	-7.1 score on scale Standard Deviation 43.8	-2.3 score on scale Standard Deviation 28.1	1.8 score on scale Standard Deviation 32.3	-9.5 score on scale Standard Deviation 39.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 27	-2.1 score on scale Standard Deviation 25.7	-6.7 score on scale Standard Deviation 36.1	0.0 score on scale Standard Deviation 21.1	13.3 score on scale Standard Deviation 38.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 3	1.6 score on scale Standard Deviation 30.3	-2.4 score on scale Standard Deviation 28.3	11.6 score on scale Standard Deviation 25.8	5.7 score on scale Standard Deviation 28.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 6	-8.3 score on scale Standard Deviation 29.3	-13.0 score on scale Standard Deviation 36.8	2.1 score on scale Standard Deviation 19.1	-1.2 score on scale Standard Deviation 29.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 9	4.9 score on scale Standard Deviation 30.2	-10.7 score on scale Standard Deviation 39.6	-3.7 score on scale Standard Deviation 22.5	0.0 score on scale Standard Deviation 23.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 21	4.2 score on scale Standard Deviation 17.9	5.6 score on scale Standard Deviation 32.1	12.1 score on scale Standard Deviation 27.0	10.3 score on scale Standard Deviation 41.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 27	10.4 score on scale Standard Deviation 31.5	-4.4 score on scale Standard Deviation 27.8	5.6 score on scale Standard Deviation 13.6	-13.3 score on scale Standard Deviation 38.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Baseline	78.4 score on scale Standard Deviation 41.5	75.5 score on scale Standard Deviation 43.4	78.6 score on scale Standard Deviation 41.8	78.4 score on scale Standard Deviation 41.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 3	7.3 score on scale Standard Deviation 34.6	7.1 score on scale Standard Deviation 46.3	0.0 score on scale Standard Deviation 52.2	3.6 score on scale Standard Deviation 42.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 6	-12.9 score on scale Standard Deviation 42.8	-8.3 score on scale Standard Deviation 55.4	6.3 score on scale Standard Deviation 68.0	-11.5 score on scale Standard Deviation 58.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 15	-16.7 score on scale Standard Deviation 64.8	-7.1 score on scale Standard Deviation 46.6	-30.8 score on scale Standard Deviation 75.1	-11.1 score on scale Standard Deviation 47.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 24	-30.0 score on scale Standard Deviation 57.1	-25.0 score on scale Standard Deviation 44.7	-23.1 score on scale Standard Deviation 59.9	-22.2 score on scale Standard Deviation 44.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 15	3.3 score on scale Standard Deviation 32.0	0.0 score on scale Standard Deviation 27.7	-7.7 score on scale Standard Deviation 49.4	5.6 score on scale Standard Deviation 23.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 3	-2.4 score on scale Standard Deviation 34.5	3.3 score on scale Standard Deviation 30.6	11.6 score on scale Standard Deviation 21.6	-4.6 score on scale Standard Deviation 19.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 12	-3.3 score on scale Standard Deviation 35.4	-9.4 score on scale Standard Deviation 39.0	11.8 score on scale Standard Deviation 23.4	0.0 score on scale Standard Deviation 24.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 15	0.0 score on scale Standard Deviation 38.5	-8.6 score on scale Standard Deviation 45.8	7.7 score on scale Standard Deviation 14.6	1.9 score on scale Standard Deviation 35.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 12	2.1 score on scale Standard Deviation 14.5	-2.5 score on scale Standard Deviation 24.3	-4.9 score on scale Standard Deviation 28.1	3.5 score on scale Standard Deviation 27.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 3	-9.5 score on scale Standard Deviation 36.3	-0.8 score on scale Standard Deviation 26.0	0.0 score on scale Standard Deviation 24.6	-12.6 score on scale Standard Deviation 32.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 15	1.0 score on scale Standard Deviation 25.4	0.6 score on scale Standard Deviation 25.0	-2.6 score on scale Standard Deviation 16.5	3.7 score on scale Standard Deviation 16.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Senses Problems; Change from Baseline at Week 18	4.2 score on scale Standard Deviation 27.8	-7.1 score on scale Standard Deviation 17.1	-1.5 score on scale Standard Deviation 11.7	6.0 score on scale Standard Deviation 26.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Speech Problems; Change from Baseline at Week 90	-22.2 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 6	-6.5 score on scale Standard Deviation 33.8	-11.8 score on scale Standard Deviation 24.5	10.4 score on scale Standard Deviation 26.4	-6.2 score on scale Standard Deviation 29.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 9	2.5 score on scale Standard Deviation 34.5	-6.2 score on scale Standard Deviation 32.1	8.8 score on scale Standard Deviation 36.6	-4.8 score on scale Standard Deviation 24.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 18	3.6 score on scale Standard Deviation 26.2	-6.7 score on scale Standard Deviation 36.0	12.1 score on scale Standard Deviation 16.8	2.4 score on scale Standard Deviation 27.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 21	2.9 score on scale Standard Deviation 26.4	1.4 score on scale Standard Deviation 38.2	3.0 score on scale Standard Deviation 10.1	0.0 score on scale Standard Deviation 27.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 24	10.0 score on scale Standard Deviation 28.8	-2.1 score on scale Standard Deviation 39.4	10.3 score on scale Standard Deviation 21.0	-3.7 score on scale Standard Deviation 20.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 27	8.9 score on scale Standard Deviation 23.5	-16.7 score on scale Standard Deviation 31.4	5.6 score on scale Standard Deviation 13.6	20.0 score on scale Standard Deviation 29.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Opening Mouth; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Baseline	42.3 score on scale Standard Deviation 35.6	38.1 score on scale Standard Deviation 36.0	34.5 score on scale Standard Deviation 33.3	49.5 score on scale Standard Deviation 37.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 6	-9.4 score on scale Standard Deviation 30.8	0.9 score on scale Standard Deviation 34.3	2.1 score on scale Standard Deviation 33.3	-13.6 score on scale Standard Deviation 29.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 12	-3.1 score on scale Standard Deviation 37.3	-5.1 score on scale Standard Deviation 40.9	-3.9 score on scale Standard Deviation 33.1	-7.0 score on scale Standard Deviation 17.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 15	-5.4 score on scale Standard Deviation 40.5	-1.2 score on scale Standard Deviation 41.1	2.6 score on scale Standard Deviation 37.2	-1.9 score on scale Standard Deviation 31.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 18	-8.3 score on scale Standard Deviation 35.3	-2.6 score on scale Standard Deviation 38.8	6.1 score on scale Standard Deviation 46.7	-11.9 score on scale Standard Deviation 21.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 21	-4.2 score on scale Standard Deviation 37.2	1.4 score on scale Standard Deviation 44.5	-3.0 score on scale Standard Deviation 48.2	-15.4 score on scale Standard Deviation 29.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 24	-4.8 score on scale Standard Deviation 38.4	-11.8 score on scale Standard Deviation 37.2	-10.3 score on scale Standard Deviation 37.0	-14.8 score on scale Standard Deviation 29.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 27	0.0 score on scale Standard Deviation 42.2	-20.0 score on scale Standard Deviation 32.9	0.0 score on scale Standard Deviation 51.6	6.7 score on scale Standard Deviation 36.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Dry Mouth; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Baseline	41.0 score on scale Standard Deviation 35.9	44.9 score on scale Standard Deviation 36.4	38.1 score on scale Standard Deviation 36.0	45.4 score on scale Standard Deviation 41.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 3	-7.1 score on scale Standard Deviation 35.7	-5.6 score on scale Standard Deviation 36.0	1.4 score on scale Standard Deviation 40.8	-1.2 score on scale Standard Deviation 27.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 6	-7.3 score on scale Standard Deviation 23.5	-8.3 score on scale Standard Deviation 38.5	0.0 score on scale Standard Deviation 29.8	-1.2 score on scale Standard Deviation 25.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 9	-1.2 score on scale Standard Deviation 38.7	-10.3 score on scale Standard Deviation 29.7	-10.5 score on scale Standard Deviation 35.2	3.2 score on scale Standard Deviation 36.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 12	-1.0 score on scale Standard Deviation 35.4	-10.1 score on scale Standard Deviation 30.6	-15.7 score on scale Standard Deviation 41.0	7.0 score on scale Standard Deviation 23.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 15	-1.0 score on scale Standard Deviation 26.1	-11.9 score on scale Standard Deviation 39.8	-11.1 score on scale Standard Deviation 35.8	0.0 score on scale Standard Deviation 30.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 18	-3.6 score on scale Standard Deviation 33.1	-10.3 score on scale Standard Deviation 33.7	-12.1 score on scale Standard Deviation 45.4	2.4 score on scale Standard Deviation 27.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 21	1.4 score on scale Standard Deviation 31.8	-12.5 score on scale Standard Deviation 40.3	-6.1 score on scale Standard Deviation 41.7	5.1 score on scale Standard Deviation 42.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 24	-3.2 score on scale Standard Deviation 29.6	-13.7 score on scale Standard Deviation 33.5	-7.7 score on scale Standard Deviation 45.4	3.7 score on scale Standard Deviation 20.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Sticky Saliva; Change from Baseline at Week 27	0.0 score on scale Standard Deviation 24.3	-26.7 score on scale Standard Deviation 22.5	-5.6 score on scale Standard Deviation 49.1	20.0 score on scale Standard Deviation 29.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Baseline	31.4 score on scale Standard Deviation 28.3	32.7 score on scale Standard Deviation 35.7	41.7 score on scale Standard Deviation 33.5	36.9 score on scale Standard Deviation 30.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 3	0.0 score on scale Standard Deviation 27.5	0.0 score on scale Standard Deviation 26.9	2.9 score on scale Standard Deviation 22.3	0.0 score on scale Standard Deviation 34.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 6	0.0 score on scale Standard Deviation 25.4	-4.6 score on scale Standard Deviation 40.0	-6.3 score on scale Standard Deviation 21.8	1.2 score on scale Standard Deviation 31.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 9	3.6 score on scale Standard Deviation 35.5	0.0 score on scale Standard Deviation 33.3	-1.8 score on scale Standard Deviation 28.3	-1.6 score on scale Standard Deviation 24.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 12	-5.2 score on scale Standard Deviation 26.9	-1.0 score on scale Standard Deviation 38.6	-7.8 score on scale Standard Deviation 36.4	8.8 score on scale Standard Deviation 31.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 15	4.3 score on scale Standard Deviation 30.7	-3.6 score on scale Standard Deviation 38.9	-2.6 score on scale Standard Deviation 34.6	-9.3 score on scale Standard Deviation 25.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 18	-4.8 score on scale Standard Deviation 31.1	2.6 score on scale Standard Deviation 37.6	0.0 score on scale Standard Deviation 21.1	7.1 score on scale Standard Deviation 26.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 21	-1.4 score on scale Standard Deviation 20.8	4.2 score on scale Standard Deviation 31.6	-6.1 score on scale Standard Deviation 25.0	2.6 score on scale Standard Deviation 34.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 24	-1.6 score on scale Standard Deviation 28.8	0.0 score on scale Standard Deviation 16.7	-17.9 score on scale Standard Deviation 29.2	3.7 score on scale Standard Deviation 26.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Coughing: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 6	-5.7 score on scale Standard Deviation 25.3	-8.3 score on scale Standard Deviation 36.9	2.1 score on scale Standard Deviation 14.8	-17.3 score on scale Standard Deviation 33.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 18	0.0 score on scale Standard Deviation 29.2	-1.4 score on scale Standard Deviation 45.6	0.0 score on scale Standard Deviation 14.9	-16.7 score on scale Standard Deviation 36.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 21	4.2 score on scale Standard Deviation 30.0	10.0 score on scale Standard Deviation 42.0	6.1 score on scale Standard Deviation 13.5	-5.1 score on scale Standard Deviation 26.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Teeth; Change from Baseline at Week 24	3.3 score on scale Standard Deviation 37.3	4.8 score on scale Standard Deviation 43.1	7.7 score on scale Standard Deviation 20.0	-22.2 score on scale Standard Deviation 44.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 12	1.0 score on scale Standard Deviation 28.7	-9.4 score on scale Standard Deviation 31.9	-2.0 score on scale Standard Deviation 30.0	-1.8 score on scale Standard Deviation 28.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 15	5.4 score on scale Standard Deviation 31.1	-15.5 score on scale Standard Deviation 36.8	2.6 score on scale Standard Deviation 28.7	5.6 score on scale Standard Deviation 34.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 18	3.6 score on scale Standard Deviation 24.6	-10.7 score on scale Standard Deviation 36.9	9.1 score on scale Standard Deviation 15.6	0.0 score on scale Standard Deviation 29.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 24	3.2 score on scale Standard Deviation 20.8	-2.0 score on scale Standard Deviation 27.6	7.7 score on scale Standard Deviation 20.0	11.1 score on scale Standard Deviation 37.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 9	-14.8 score on scale Standard Deviation 45.6	3.4 score on scale Standard Deviation 32.5	-10.5 score on scale Standard Deviation 56.7	-14.3 score on scale Standard Deviation 47.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 12	-20.0 score on scale Standard Deviation 48.4	-9.1 score on scale Standard Deviation 52.2	-17.6 score on scale Standard Deviation 52.9	0.0 score on scale Standard Deviation 33.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 18	-21.4 score on scale Standard Deviation 63.0	-4.0 score on scale Standard Deviation 45.5	0.0 score on scale Standard Deviation 77.5	-13.3 score on scale Standard Deviation 51.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 21	-30.4 score on scale Standard Deviation 63.5	-12.5 score on scale Standard Deviation 53.7	-33.3 score on scale Standard Deviation 65.1	-15.4 score on scale Standard Deviation 37.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 27	-35.7 score on scale Standard Deviation 63.3	-13.3 score on scale Standard Deviation 51.6	-33.3 score on scale Standard Deviation 51.6	-20.0 score on scale Standard Deviation 44.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Pain Killers; Change from Baseline at Week 90	-100.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Baseline	34.0 score on scale Standard Deviation 47.9	47.9 score on scale Standard Deviation 50.5	42.9 score on scale Standard Deviation 50.4	48.6 score on scale Standard Deviation 50.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 3	4.9 score on scale Standard Deviation 44.4	12.2 score on scale Standard Deviation 51.0	13.0 score on scale Standard Deviation 45.8	0.0 score on scale Standard Deviation 53.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 6	-9.7 score on scale Standard Deviation 53.9	-5.6 score on scale Standard Deviation 58.3	6.3 score on scale Standard Deviation 57.4	-12.0 score on scale Standard Deviation 52.6	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 9	3.7 score on scale Standard Deviation 64.9	-7.1 score on scale Standard Deviation 66.3	0.0 score on scale Standard Deviation 57.7	5.0 score on scale Standard Deviation 60.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 12	17.2 score on scale Standard Deviation 65.8	-6.3 score on scale Standard Deviation 56.4	0.0 score on scale Standard Deviation 50.0	-15.8 score on scale Standard Deviation 50.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 15	3.3 score on scale Standard Deviation 61.5	-3.7 score on scale Standard Deviation 58.7	-15.4 score on scale Standard Deviation 55.5	-11.1 score on scale Standard Deviation 47.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 18	-7.1 score on scale Standard Deviation 60.4	-4.2 score on scale Standard Deviation 62.4	0.0 score on scale Standard Deviation 44.7	6.7 score on scale Standard Deviation 59.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 21	4.3 score on scale Standard Deviation 63.8	4.3 score on scale Standard Deviation 63.8	16.7 score on scale Standard Deviation 57.7	23.1 score on scale Standard Deviation 59.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 24	15.0 score on scale Standard Deviation 48.9	11.8 score on scale Standard Deviation 69.7	-15.4 score on scale Standard Deviation 55.5	-11.1 score on scale Standard Deviation 60.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Baseline	28.0 score on scale Standard Deviation 45.4	27.1 score on scale Standard Deviation 44.9	28.6 score on scale Standard Deviation 46.0	32.4 score on scale Standard Deviation 47.5	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 3	4.9 score on scale Standard Deviation 38.4	4.9 score on scale Standard Deviation 21.8	4.3 score on scale Standard Deviation 20.9	-6.9 score on scale Standard Deviation 25.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 6	0.0 score on scale Standard Deviation 25.8	-5.7 score on scale Standard Deviation 33.8	-6.7 score on scale Standard Deviation 25.8	-7.7 score on scale Standard Deviation 39.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 9	-11.1 score on scale Standard Deviation 32.0	7.1 score on scale Standard Deviation 26.2	5.3 score on scale Standard Deviation 40.5	-4.8 score on scale Standard Deviation 38.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 12	-3.4 score on scale Standard Deviation 32.5	6.1 score on scale Standard Deviation 34.8	-5.9 score on scale Standard Deviation 42.9	0.0 score on scale Standard Deviation 33.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 18	-3.6 score on scale Standard Deviation 33.1	4.3 score on scale Standard Deviation 20.9	-9.1 score on scale Standard Deviation 30.2	0.0 score on scale Standard Deviation 37.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 21	-4.3 score on scale Standard Deviation 36.7	4.3 score on scale Standard Deviation 20.9	-16.7 score on scale Standard Deviation 38.9	7.7 score on scale Standard Deviation 27.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 24	0.0 score on scale Standard Deviation 32.4	5.9 score on scale Standard Deviation 24.3	-15.4 score on scale Standard Deviation 37.6	0.0 score on scale Standard Deviation 0.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 27	0.0 score on scale Standard Deviation 0.0	7.7 score on scale Standard Deviation 27.7	-16.7 score on scale Standard Deviation 40.8	0.0 score on scale Standard Deviation 0.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Feeding Tube; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Baseline	32.0 score on scale Standard Deviation 47.1	44.9 score on scale Standard Deviation 50.3	28.6 score on scale Standard Deviation 46.0	29.7 score on scale Standard Deviation 46.3	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 3	23.1 score on scale Standard Deviation 62.7	-4.9 score on scale Standard Deviation 59.0	30.4 score on scale Standard Deviation 55.9	10.3 score on scale Standard Deviation 61.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 6	-6.7 score on scale Standard Deviation 74.0	-13.9 score on scale Standard Deviation 59.3	12.5 score on scale Standard Deviation 50.0	19.2 score on scale Standard Deviation 63.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 9	3.7 score on scale Standard Deviation 70.6	-17.2 score on scale Standard Deviation 60.2	0.0 score on scale Standard Deviation 57.7	-9.5 score on scale Standard Deviation 53.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 12	-17.2 score on scale Standard Deviation 46.8	-18.2 score on scale Standard Deviation 58.4	11.8 score on scale Standard Deviation 33.2	-5.3 score on scale Standard Deviation 52.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 15	13.3 score on scale Standard Deviation 73.0	-10.7 score on scale Standard Deviation 73.7	15.4 score on scale Standard Deviation 37.6	-5.9 score on scale Standard Deviation 65.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 18	0.0 score on scale Standard Deviation 60.9	-20.0 score on scale Standard Deviation 57.7	0.0 score on scale Standard Deviation 44.7	6.7 score on scale Standard Deviation 59.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 21	4.3 score on scale Standard Deviation 47.5	-4.2 score on scale Standard Deviation 75.1	25.0 score on scale Standard Deviation 45.2	7.7 score on scale Standard Deviation 76.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 24	-5.0 score on scale Standard Deviation 39.4	-5.9 score on scale Standard Deviation 65.9	7.7 score on scale Standard Deviation 49.4	33.3 score on scale Standard Deviation 50.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 27	0.0 score on scale Standard Deviation 55.5	-13.3 score on scale Standard Deviation 74.3	0.0 score on scale Standard Deviation 0.0	40.0 score on scale Standard Deviation 54.8	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Loss; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Baseline	14.3 score on scale Standard Deviation 35.4	8.2 score on scale Standard Deviation 27.7	21.4 score on scale Standard Deviation 41.8	18.9 score on scale Standard Deviation 39.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 3	7.7 score on scale Standard Deviation 53.2	27.5 score on scale Standard Deviation 55.4	4.3 score on scale Standard Deviation 36.7	-6.9 score on scale Standard Deviation 53.0	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 6	10.0 score on scale Standard Deviation 54.8	25.0 score on scale Standard Deviation 43.9	0.0 score on scale Standard Deviation 63.2	7.7 score on scale Standard Deviation 48.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 9	3.8 score on scale Standard Deviation 59.9	14.3 score on scale Standard Deviation 44.8	5.6 score on scale Standard Deviation 63.9	19.0 score on scale Standard Deviation 60.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 12	14.3 score on scale Standard Deviation 52.5	6.3 score on scale Standard Deviation 50.4	23.5 score on scale Standard Deviation 43.7	26.3 score on scale Standard Deviation 56.2	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 15	6.7 score on scale Standard Deviation 58.3	25.0 score on scale Standard Deviation 64.5	0.0 score on scale Standard Deviation 40.8	11.1 score on scale Standard Deviation 47.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 18	7.4 score on scale Standard Deviation 38.5	16.7 score on scale Standard Deviation 56.5	-18.2 score on scale Standard Deviation 60.3	6.7 score on scale Standard Deviation 59.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 21	18.2 score on scale Standard Deviation 39.5	4.2 score on scale Standard Deviation 55.0	0.0 score on scale Standard Deviation 73.9	15.4 score on scale Standard Deviation 68.9	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 24	21.1 score on scale Standard Deviation 63.1	17.6 score on scale Standard Deviation 52.9	0.0 score on scale Standard Deviation 40.8	11.1 score on scale Standard Deviation 60.1	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 27	28.6 score on scale Standard Deviation 61.1	33.3 score on scale Standard Deviation 61.7	-16.7 score on scale Standard Deviation 40.8	20.0 score on scale Standard Deviation 44.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Weight Gain; Change from Baseline at Week 90	-100.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Felt Ill: Baseline	24.4 score on scale Standard Deviation 31.0	31.9 score on scale Standard Deviation 35.4	27.4 score on scale Standard Deviation 27.3	22.5 score on scale Standard Deviation 28.4	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 27	14.3 score on scale Standard Deviation 36.3	7.1 score on scale Standard Deviation 82.9	-16.7 score on scale Standard Deviation 40.8	0.0 score on scale Standard Deviation 70.7	—	—
Phase 2 Cohorts: Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life - Head and Neck Module (EORTC QLQ-H&N35) Parameter: Symptom Scales / Items: Nutritional Supplements; Change from Baseline at Week 90	0.0 score on scale Standard Deviation NA The Standard Deviation can not be calculated for one participant.	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants per category are reported.

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=51 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=50 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=27 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=36 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 9 · No Problems	19 Participants	21 Participants	12 Participants	12 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 15 · Moderate Problems	1 Participants	5 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Baseline · Slight Problems	9 Participants	10 Participants	4 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Baseline · Moderate Problems	5 Participants	7 Participants	2 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Baseline · Severe Problems	2 Participants	1 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Baseline · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 3 · No Problems	29 Participants	28 Participants	13 Participants	16 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 3 · Slight Problems	7 Participants	10 Participants	5 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 3 · Moderate Problems	4 Participants	3 Participants	3 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 3 · Severe Problems	2 Participants	2 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 3 · Extreme Problems	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 6 · No Problems	17 Participants	28 Participants	11 Participants	12 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 6 · Slight Problems	7 Participants	9 Participants	3 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Baseline · No Problems	35 Participants	31 Participants	19 Participants	18 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 6 · Moderate Problems	3 Participants	1 Participants	2 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 6 · Severe Problems	1 Participants	1 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 6 · Extreme Problems	2 Participants	1 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 9 · Slight Problems	5 Participants	5 Participants	5 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 9 · Moderate Problems	4 Participants	2 Participants	1 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 9 · Severe Problems	1 Participants	1 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 9 · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 12 · No Problems	18 Participants	22 Participants	12 Participants	11 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 12 · Slight Problems	9 Participants	6 Participants	4 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 12 · Moderate Problems	2 Participants	4 Participants	2 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 12 · Severe Problems	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 12 · Extreme Problems	1 Participants	1 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 15 · No Problems	22 Participants	17 Participants	9 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 15 · Slight Problems	5 Participants	7 Participants	2 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 15 · Severe Problems	3 Participants	1 Participants	1 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 15 · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 18 · No Problems	19 Participants	18 Participants	10 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 18 · Slight Problems	5 Participants	3 Participants	1 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 18 · Moderate Problems	2 Participants	1 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 18 · Severe Problems	3 Participants	2 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 18 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 21 · No Problems	15 Participants	11 Participants	9 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 21 · Slight Problems	6 Participants	8 Participants	1 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 21 · Moderate Problems	2 Participants	3 Participants	1 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 21 · Severe Problems	1 Participants	0 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 21 · Extreme Problems	0 Participants	2 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 24 · No Problems	15 Participants	5 Participants	11 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 24 · Slight Problems	4 Participants	8 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 24 · Moderate Problems	1 Participants	4 Participants	2 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 24 · Severe Problems	1 Participants	1 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 24 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 27 · No Problems	9 Participants	7 Participants	5 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 27 · Slight Problems	4 Participants	5 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 27 · Moderate Problems	2 Participants	0 Participants	0 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 27 · Severe Problems	0 Participants	2 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 27 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 90 · No Problems	1 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 90 · Slight Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 90 · Moderate Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 90 · Severe Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Mobility: Week 90 · Extreme Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Baseline · No Problems	38 Participants	38 Participants	23 Participants	30 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Baseline · Slight Problems	6 Participants	8 Participants	3 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Baseline · Moderate Problems	3 Participants	2 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Baseline · Severe Problems	3 Participants	0 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Baseline · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 21 · Slight Problems	4 Participants	5 Participants	1 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 21 · Moderate Problems	1 Participants	1 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 21 · Severe Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 21 · Extreme Problems	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 24 · No Problems	17 Participants	15 Participants	11 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 24 · Slight Problems	2 Participants	0 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 24 · Moderate Problems	2 Participants	2 Participants	1 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 24 · Severe Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 24 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 27 · No Problems	12 Participants	12 Participants	6 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 27 · Slight Problems	1 Participants	1 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 27 · Moderate Problems	2 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 27 · Severe Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 27 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 90 · No Problems	1 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 90 · Slight Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 90 · Moderate Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 90 · Severe Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 90 · Extreme Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Baseline · No Problems	25 Participants	24 Participants	14 Participants	15 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Baseline · Slight Problems	13 Participants	14 Participants	9 Participants	12 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Baseline · Moderate Problems	8 Participants	7 Participants	1 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Baseline · Severe Problems	4 Participants	1 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Baseline · Extreme Problems	1 Participants	3 Participants	0 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 3 · No Problems	16 Participants	19 Participants	8 Participants	10 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 3 · Slight Problems	17 Participants	15 Participants	9 Participants	11 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 3 · Moderate Problems	5 Participants	6 Participants	4 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 3 · Severe Problems	3 Participants	2 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 3 · Extreme Problems	1 Participants	0 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 6 · No Problems	16 Participants	21 Participants	8 Participants	12 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 6 · Slight Problems	10 Participants	12 Participants	3 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 6 · Moderate Problems	2 Participants	5 Participants	5 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 6 · Severe Problems	1 Participants	1 Participants	0 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 6 · Extreme Problems	1 Participants	1 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 9 · No Problems	14 Participants	19 Participants	10 Participants	11 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 9 · Slight Problems	11 Participants	4 Participants	3 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 9 · Moderate Problems	4 Participants	5 Participants	6 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 9 · Severe Problems	0 Participants	2 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 9 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 12 · No Problems	16 Participants	21 Participants	13 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 12 · Slight Problems	10 Participants	8 Participants	3 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 12 · Moderate Problems	1 Participants	3 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 12 · Severe Problems	2 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 12 · Extreme Problems	2 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 15 · No Problems	15 Participants	15 Participants	6 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 15 · Slight Problems	8 Participants	8 Participants	4 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 15 · Moderate Problems	5 Participants	5 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 15 · Severe Problems	2 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 15 · Extreme Problems	0 Participants	1 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 18 · No Problems	18 Participants	15 Participants	7 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 18 · Slight Problems	6 Participants	7 Participants	4 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 18 · Moderate Problems	2 Participants	2 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 18 · Severe Problems	2 Participants	0 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 18 · Extreme Problems	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 21 · No Problems	15 Participants	11 Participants	8 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 21 · Slight Problems	9 Participants	9 Participants	1 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 21 · Moderate Problems	0 Participants	2 Participants	2 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 21 · Severe Problems	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 21 · Extreme Problems	0 Participants	1 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 24 · No Problems	12 Participants	10 Participants	7 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 24 · Slight Problems	5 Participants	4 Participants	3 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 24 · Moderate Problems	2 Participants	1 Participants	3 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 24 · Severe Problems	1 Participants	2 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 24 · Extreme Problems	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 27 · No Problems	8 Participants	8 Participants	4 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 27 · Slight Problems	4 Participants	3 Participants	2 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 27 · Moderate Problems	3 Participants	1 Participants	0 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 27 · Severe Problems	0 Participants	2 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 27 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 90 · No Problems	1 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 90 · Slight Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 90 · Moderate Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 90 · Severe Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Usual Activities: Week 90 · Extreme Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Baseline · No Problems	9 Participants	10 Participants	4 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Baseline · Slight Problems	19 Participants	16 Participants	8 Participants	12 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Baseline · Moderate Problems	15 Participants	15 Participants	11 Participants	12 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Baseline · Severe Problems	6 Participants	8 Participants	2 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Baseline · Extreme Problems	2 Participants	1 Participants	2 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 3 · No Problems	12 Participants	12 Participants	5 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 3 · Slight Problems	17 Participants	12 Participants	5 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 3 · Moderate Problems	10 Participants	15 Participants	7 Participants	10 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 3 · Severe Problems	3 Participants	4 Participants	5 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 3 · Extreme Problems	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 6 · No Problems	10 Participants	16 Participants	4 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 6 · Slight Problems	15 Participants	10 Participants	7 Participants	10 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 6 · Moderate Problems	5 Participants	11 Participants	4 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 6 · Severe Problems	0 Participants	3 Participants	1 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 6 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 9 · No Problems	10 Participants	10 Participants	6 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 9 · Slight Problems	9 Participants	9 Participants	7 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 9 · Moderate Problems	8 Participants	8 Participants	5 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 9 · Severe Problems	2 Participants	3 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 9 · Extreme Problems	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 12 · No Problems	11 Participants	11 Participants	10 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 12 · Slight Problems	11 Participants	15 Participants	4 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 12 · Moderate Problems	5 Participants	6 Participants	3 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 12 · Severe Problems	3 Participants	1 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 12 · Extreme Problems	1 Participants	1 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 15 · No Problems	10 Participants	11 Participants	4 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 15 · Slight Problems	13 Participants	7 Participants	5 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 15 · Moderate Problems	5 Participants	9 Participants	3 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 15 · Severe Problems	3 Participants	3 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 15 · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 18 · No Problems	10 Participants	11 Participants	4 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 18 · Slight Problems	11 Participants	8 Participants	3 Participants	7 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 18 · Moderate Problems	8 Participants	5 Participants	4 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 18 · Severe Problems	0 Participants	0 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 18 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 21 · No Problems	9 Participants	11 Participants	8 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 21 · Slight Problems	7 Participants	4 Participants	2 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 21 · Moderate Problems	5 Participants	6 Participants	3 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 21 · Severe Problems	3 Participants	3 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 21 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 24 · No Problems	7 Participants	7 Participants	5 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 24 · Slight Problems	7 Participants	4 Participants	6 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 24 · Moderate Problems	7 Participants	6 Participants	1 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 24 · Severe Problems	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 24 · Extreme Problems	0 Participants	1 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 27 · No Problems	9 Participants	9 Participants	4 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 27 · Slight Problems	1 Participants	0 Participants	2 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 27 · Moderate Problems	4 Participants	2 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 27 · Severe Problems	1 Participants	3 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 27 · Extreme Problems	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 90 · No Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 90 · Slight Problems	1 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 90 · Moderate Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 90 · Severe Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Pain/Discomfort: Week 90 · Extreme Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Baseline · No Problems	20 Participants	21 Participants	9 Participants	22 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Baseline · Slight Problems	20 Participants	15 Participants	12 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Baseline · Moderate Problems	6 Participants	8 Participants	5 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Baseline · Severe Problems	4 Participants	3 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Baseline · Extreme Problems	1 Participants	3 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 3 · No Problems	21 Participants	23 Participants	8 Participants	16 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 3 · Slight Problems	15 Participants	7 Participants	11 Participants	10 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 3 · Moderate Problems	3 Participants	9 Participants	3 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 3 · Severe Problems	3 Participants	4 Participants	1 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 3 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 6 · No Problems	16 Participants	19 Participants	8 Participants	13 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 6 · Slight Problems	13 Participants	10 Participants	5 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 6 · Moderate Problems	1 Participants	7 Participants	3 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 6 · Severe Problems	0 Participants	3 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 6 · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 9 · No Problems	8 Participants	18 Participants	8 Participants	11 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 9 · Slight Problems	15 Participants	8 Participants	9 Participants	8 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 9 · Moderate Problems	6 Participants	3 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 9 · Severe Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 9 · Extreme Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 12 · No Problems	14 Participants	15 Participants	9 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 12 · Slight Problems	14 Participants	15 Participants	9 Participants	9 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 12 · Moderate Problems	0 Participants	4 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 12 · Severe Problems	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 12 · Extreme Problems	2 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 15 · No Problems	15 Participants	14 Participants	6 Participants	10 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 15 · Slight Problems	11 Participants	6 Participants	5 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 15 · Moderate Problems	3 Participants	8 Participants	1 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 15 · Severe Problems	1 Participants	3 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 15 · Extreme Problems	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 18 · No Problems	14 Participants	13 Participants	4 Participants	10 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 18 · Slight Problems	9 Participants	6 Participants	5 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 18 · Moderate Problems	4 Participants	5 Participants	1 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 18 · Severe Problems	2 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 18 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 21 · No Problems	12 Participants	12 Participants	8 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 21 · Slight Problems	7 Participants	4 Participants	4 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 21 · Moderate Problems	4 Participants	7 Participants	1 Participants	4 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 21 · Severe Problems	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 21 · Extreme Problems	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 24 · No Problems	10 Participants	10 Participants	8 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 24 · Slight Problems	8 Participants	3 Participants	5 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 24 · Moderate Problems	2 Participants	4 Participants	0 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 24 · Severe Problems	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 24 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 27 · No Problems	7 Participants	7 Participants	4 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 27 · Slight Problems	4 Participants	4 Participants	2 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 27 · Moderate Problems	3 Participants	1 Participants	0 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 27 · Severe Problems	1 Participants	2 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 27 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 90 · No Problems	1 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 90 · Slight Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 90 · Moderate Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 90 · Severe Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Anxiety/Depression: Week 90 · Extreme Problems	0 Participants	—	—	—	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 3 · No Problems	31 Participants	32 Participants	16 Participants	21 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 3 · Slight Problems	5 Participants	7 Participants	5 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 3 · Moderate Problems	5 Participants	4 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 3 · Severe Problems	1 Participants	0 Participants	2 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 3 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 6 · No Problems	25 Participants	34 Participants	13 Participants	19 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 6 · Slight Problems	3 Participants	3 Participants	3 Participants	6 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 6 · Moderate Problems	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 6 · Severe Problems	0 Participants	2 Participants	0 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 6 · Extreme Problems	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 9 · No Problems	22 Participants	24 Participants	16 Participants	17 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 9 · Slight Problems	5 Participants	4 Participants	2 Participants	3 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 9 · Moderate Problems	2 Participants	1 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 9 · Severe Problems	0 Participants	1 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 9 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 12 · No Problems	24 Participants	27 Participants	15 Participants	17 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 12 · Slight Problems	5 Participants	3 Participants	2 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 12 · Moderate Problems	0 Participants	4 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 12 · Severe Problems	2 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 12 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 15 · No Problems	24 Participants	25 Participants	10 Participants	13 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 15 · Slight Problems	4 Participants	4 Participants	1 Participants	5 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 15 · Moderate Problems	2 Participants	1 Participants	1 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 15 · Severe Problems	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 15 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 18 · No Problems	22 Participants	21 Participants	10 Participants	13 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 18 · Slight Problems	4 Participants	2 Participants	1 Participants	2 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 18 · Moderate Problems	1 Participants	0 Participants	0 Participants	1 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 18 · Severe Problems	2 Participants	1 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 18 · Extreme Problems	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Phase 2 Cohorts: Number of Participants With 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score Self-Care: Week 21 · No Problems	18 Participants	17 Participants	12 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 3, Week 6, Week 9, Week 12, Week 15, Week 18, Week 21, Week 24, Week 27 and Week 90

The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".

Outcome measures

Outcome measures
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 Participants Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=52 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=32 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=41 Participants Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.	Safety Run-in Cohort 2: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Baseline	61.9 score on scale Standard Deviation 20.96	64.0 score on scale Standard Deviation 23.15	59.8 score on scale Standard Deviation 24.86	62.0 score on scale Standard Deviation 22.21	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 3	-3.7 score on scale Standard Deviation 20.80	4.3 score on scale Standard Deviation 20.72	4.1 score on scale Standard Deviation 17.88	-0.3 score on scale Standard Deviation 16.20	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 6	2.2 score on scale Standard Deviation 14.82	5.7 score on scale Standard Deviation 24.75	1.1 score on scale Standard Deviation 15.71	-2.1 score on scale Standard Deviation 16.37	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 9	-1.0 score on scale Standard Deviation 18.19	2.5 score on scale Standard Deviation 16.89	6.6 score on scale Standard Deviation 18.50	4.4 score on scale Standard Deviation 20.74	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 12	4.5 score on scale Standard Deviation 18.65	7.9 score on scale Standard Deviation 23.02	5.9 score on scale Standard Deviation 19.60	-4.5 score on scale Standard Deviation 14.55	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 15	0.1 score on scale Standard Deviation 18.79	10.5 score on scale Standard Deviation 23.60	3.2 score on scale Standard Deviation 15.05	-1.1 score on scale Standard Deviation 12.86	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 18	-1.2 score on scale Standard Deviation 19.34	7.4 score on scale Standard Deviation 23.33	3.8 score on scale Standard Deviation 20.11	-8.1 score on scale Standard Deviation 17.77	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 21	0.5 score on scale Standard Deviation 18.59	1.1 score on scale Standard Deviation 21.12	4.0 score on scale Standard Deviation 20.15	-8.5 score on scale Standard Deviation 16.71	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 24	0.2 score on scale Standard Deviation 22.05	6.0 score on scale Standard Deviation 22.45	2.1 score on scale Standard Deviation 20.72	-13.9 score on scale Standard Deviation 19.17	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 27	-10.0 score on scale Standard Deviation 19.32	-0.9 score on scale Standard Deviation 22.46	10.0 score on scale Standard Deviation 21.45	-9.0 score on scale Standard Deviation 23.56	—	—
Phase 2 Cohorts: Change From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score Change at Week 90	25.0 score on scale Standard Deviation NA Standard Deviation can not be estimated for one participant.	—	—	—	—	—

Adverse Events

Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU

Serious events: 4 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase 2 Cohort 1 Arm A: Magrolimab + Pembrolizumab + Platinum + 5-FU

Serious events: 26 serious events

Other events: 49 other events

Deaths: 25 deaths

Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU

Serious events: 24 serious events

Other events: 53 other events

Deaths: 22 deaths

Phase 2 Cohort 1 Arm C: Magrolimab + Zimberelimab + Platinum + 5-FU

Serious events: 15 serious events

Other events: 28 other events

Deaths: 9 deaths

Safety Run-in Cohort 2: Magrolimab + Docetaxel

Serious events: 6 serious events

Other events: 7 other events

Deaths: 6 deaths

Phase 2 Cohort 3: Magrolimab + Docetaxel

Serious events: 24 serious events

Other events: 40 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Safety Run-in Cohort 1: Magrolimab + Pembrolizumab + Platinum + 5-FU n=6 participants at risk Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Phase 2 Cohort 1 Arm A: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 participants at risk Participants received magrolimab + pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 72 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 88 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 22 weeks for carboplatin and 23 weeks for cisplatin.	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU n=53 participants at risk Participants received pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 70 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks for carboplatin and 18 weeks for cisplatin.	Phase 2 Cohort 1 Arm C: Magrolimab + Zimberelimab + Platinum + 5-FU n=29 participants at risk Participants received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of every 21-day cycle for up to 40 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18 weeks for carboplatin and 16 weeks for cisplatin.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=7 participants at risk Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=41 participants at risk Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 3/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	19.5% 8/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Leukopenia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Pancytopenia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Splenic haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Acute myocardial infarction	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 fibrillation	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Cardiac arrest	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Cardiac tamponade	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Cardio-respiratory arrest	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Myocardial infarction	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Endocrine disorders Hypothyroidism	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 upper	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Aphthous ulcer	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Ascites	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Dysphagia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Gastric ulcer perforation	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Neutropenic colitis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Oral cavity fistula	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Catheter site haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Hyperthermia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Mucosal inflammation	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Hepatic cytolysis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Anal abscess	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 viral	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Cellulitis staphylococcal	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Enterocolitis infectious	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Epididymitis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Erysipelas	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 cryptosporidial	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Genital herpes simplex	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Hepatic infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Localised infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Lung abscess	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Oral fungal infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Oral infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Pharyngeal abscess	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	66.7% 4/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.6% 6/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 aspiration	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 bacterial	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 necrotising	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Septic shock	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Staphylococcal sepsis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Subcutaneous abscess	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Systemic candida	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Tongue abscess	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Tooth infection	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Tracheitis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Clavicle fracture	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Craniocerebral injury	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Femur fracture	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Post procedural haematoma	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Post procedural haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Stoma site discharge	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Type 2 diabetes mellitus	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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) Cancer pain	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Middle cerebral artery stroke	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Seizure	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Delirium	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Disorientation	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Nephrolithiasis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Acquired tracheo-oesophageal fistula	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Pharyngeal haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 haemorrhage	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Toxic skin eruption	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Peripheral embolism	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Peripheral ischaemia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Superior vena cava syndrome	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Thrombophlebitis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Septic shock from neutropenic colitis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 + Pembrolizumab + Platinum + 5-FU n=6 participants at risk Participants received magrolimab + pembrolizumab + platinum + 5 FU (5-fluorouracil) intravenous (IV) infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 73 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 73 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18.3 weeks (for carboplatin).	Phase 2 Cohort 1 Arm A: Magrolimab + Pembrolizumab + Platinum + 5-FU n=52 participants at risk Participants received magrolimab + pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 72 weeks; Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 88 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 22 weeks for carboplatin and 23 weeks for cisplatin.	Phase 2 Cohort 1 Arm B: Pembrolizumab + Platinum + 5-FU n=53 participants at risk Participants received pembrolizumab + platinum + 5 FU IV infusions as mentioned below: Pembrolizumab 200 mg IV on Day 1 of every 21-day cycle for up to 70 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 24 weeks for carboplatin and 18 weeks for cisplatin.	Phase 2 Cohort 1 Arm C: Magrolimab + Zimberelimab + Platinum + 5-FU n=29 participants at risk Participants received magrolimab + zimberelimab + platinum + 5 FU IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 37 weeks; Zimberelimab 360 mg IV on Day 1 of every 21-day cycle for up to 40 weeks; 5-FU 1000 mg/m\^2/day continuous IV On Day 1 to 4 of Cycles 1 to 6 for 21-day cycle each for up to 19 weeks; Cisplatin 100 mg/m\^2 IV or Carboplatin AUC 5 IV on Day 1 of Cycles 1 to 6 for 21-day cycle each for up to 18 weeks for carboplatin and 16 weeks for cisplatin.	Safety Run-in Cohort 2: Magrolimab + Docetaxel n=7 participants at risk Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 69 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 13 weeks.	Phase 2 Cohort 3: Magrolimab + Docetaxel n=41 participants at risk Participants received magrolimab + docetaxel IV infusions as mentioned below: Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses (Cycle 1 Days 8, 15, and Cycle 2 Days 1, 8 and 15); 60 mg/kg, starting Cycle 3 Day 1 onwards for every 21-day cycle for up to 42 weeks; Docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day cycle for up to 34 weeks.
Blood and lymphatic system disorders Anaemia	83.3% 5/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	82.7% 43/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	69.8% 37/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	72.4% 21/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 5/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	68.3% 28/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Leukopenia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.2% 7/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.3% 9/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.3% 6/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Pain	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 16/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	22.6% 12/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.1% 7/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	19.5% 8/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 16/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	37.7% 20/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.2% 5/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Cardiac failure congestive	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Ventricular hypokinesia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Ear and labyrinth disorders Hypoacusis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.5% 6/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
Endocrine disorders Hypothyroidism	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Blindness unilateral	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 upper	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	34.6% 18/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	30.2% 16/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.1% 7/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.2% 11/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.5% 13/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.1% 7/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	34.1% 14/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Dysphagia	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Glossodynia	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	66.7% 4/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	36.5% 19/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	43.4% 23/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	37.9% 11/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	36.6% 15/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Oral dysaesthesia	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Oral pain	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	83.3% 5/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.5% 7/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	34.0% 18/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 9/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.4% 10/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.5% 6/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.2% 7/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.1% 7/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.6% 6/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Asthenia	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 16/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	28.3% 15/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	34.5% 10/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.1% 7/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	83.3% 5/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 12/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	20.8% 11/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 9/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	34.1% 14/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Mucosal inflammation	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.5% 6/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Candida infection	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Cellulitis	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Device related infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Ear infection	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Furuncle	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Localised infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Oral candidiasis	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Respiratory tract infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Stoma site infection	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	20.7% 6/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Limb injury	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Stoma site pain	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.5% 7/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 creatinine increased	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 thyroid stimulating hormone increased	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Haemoglobin decreased	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.5% 6/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.2% 11/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	22.0% 9/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	83.3% 5/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 8/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.1% 8/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	27.6% 8/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 3/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.2% 7/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.2% 5/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	66.7% 4/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	21.2% 11/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	19.5% 8/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	26.9% 14/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	18.9% 10/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 3/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.4% 10/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Failure to thrive	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.6% 6/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.5% 7/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	18.9% 10/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	20.7% 6/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.6% 6/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	19.2% 10/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	15.1% 8/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	27.6% 8/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.5% 7/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.0% 9/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	27.6% 8/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	14.6% 6/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.5% 6/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	27.6% 8/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.8% 4/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 tightness	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 jaw	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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) Cancer pain	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Brain fog	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Disturbance in attention	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	19.2% 10/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.4% 5/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	27.6% 8/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.1% 7/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.8% 4/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Polyneuropathy	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Depression	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.5% 4/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Proteinuria	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	13.2% 7/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.2% 5/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	12.2% 5/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 8/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	11.3% 6/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	17.2% 5/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	24.4% 10/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 exertional	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Hiccups	33.3% 2/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	4.9% 2/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Increased bronchial secretion	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Laryngeal inflammation	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Tracheal inflammation	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Actinic keratosis	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	10.3% 3/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	22.0% 9/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Palmar-plantar erythrodysaesthesia syndrome	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	9.6% 5/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	1.9% 1/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	50.0% 3/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 4/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 pruritic	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 fissures	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 hyperpigmentation	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 Embolism	0.00% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	6.9% 2/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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	16.7% 1/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.8% 2/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	3.4% 1/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 1/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 0/6 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.8% 3/52 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	5.7% 3/53 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	0.00% 0/29 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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% 2/7 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.	7.3% 3/41 • All-Cause Mortality: Up to 129 weeks; Adverse Events: Up to 73 weeks plus 30 days All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number 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 (GILEAD-0)

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