Trial Outcomes & Findings for Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT02303821)

Last Updated: 2025-06-04

Results Overview

An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. Treatment-related AEs (TRAEs) were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

141 participants

Primary outcome timeframe

From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks

Results posted on

2025-06-04

Participant Flow

Participants were recruited in Australia, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, France, Greece, Hong Kong, Italy, Israel, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, the UK and the US between February 2015 and June 2024.

Phase 1b: Participants underwent a 4-week induction and 4-week consolidation cycle, receiving two treatments. Phase 2: After a 7-day screening, participants received VXLD (vincristine, PEG-asparaginase, daunorubicin, dexamethasone) with carfilzomib during a 28-day induction. One B-cell group participant did not receive carfilzomib and was excluded from the primary analysis. Participants were followed for up to 2 years post-treatment.

Participant milestones

Participant milestones
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 intravenously (IV) for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 2: B-cell (20/56 mg/m^2) Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	Phase 2: T-cell (20/56 mg/m^2) Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Overall Study STARTED	5	6	3	7	4	10	62	44
Overall Study Received Carfilzomib During Induction Therapy	5	6	3	7	4	10	61	44
Overall Study Received Carfilzomib During Consolidation Therapy	2	1	1	5	3	3	25	20
Overall Study COMPLETED	5	3	3	7	4	5	19	13
Overall Study NOT COMPLETED	0	3	0	0	0	5	43	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 2: B-cell (20/56 mg/m^2) Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	Phase 2: T-cell (20/56 mg/m^2) Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Overall Study Withdrawal by Subject	0	0	0	2
Overall Study Death	2	3	41	29
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Withdrawal prior to Carfilzomib dosing	0	0	1	0
Overall Study Decision by sponsor	0	1	0	0
Overall Study Protocol-specified criteria	1	1	0	0

Baseline Characteristics

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=6 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=7 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=10 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 2: B-cell (20/56 mg/m^2) n=61 Participants Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	Phase 2: T-cell (20/56 mg/m^2) n=44 Participants Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	Total n=140 Participants Total of all reporting groups
Age, Customized < 1 month	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Customized 1 month - <= 17 years	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=10 Participants	57 Participants n=115 Participants	41 Participants n=24 Participants	131 Participants n=42 Participants
Age, Customized > 17 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	3 Participants n=24 Participants	9 Participants n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	19 Participants n=115 Participants	5 Participants n=24 Participants	35 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	42 Participants n=115 Participants	39 Participants n=24 Participants	105 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	28 Participants n=115 Participants	11 Participants n=24 Participants	43 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	10 Participants n=10 Participants	33 Participants n=115 Participants	33 Participants n=24 Participants	97 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	9 Participants n=115 Participants	6 Participants n=24 Participants	16 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=24 Participants	7 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	38 Participants n=115 Participants	33 Participants n=24 Participants	99 Participants n=42 Participants
Race/Ethnicity, Customized Other (Indian, Brown, Brazilian indigenous, Hispanic Mestizo, Mestizo breed, Hispanic, and Mixed)	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	9 Participants n=115 Participants	1 Participants n=24 Participants	13 Participants n=42 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks

Population: Phase 1b Safety Analysis Set: All participants who received any amount of the study treatment regimen.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=6 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=7 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=10 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All TEAEs	5 Participants	6 Participants	3 Participants	7 Participants	4 Participants	9 Participants
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All fatal TEAEs	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All TRAEs	5 Participants	4 Participants	3 Participants	7 Participants	4 Participants	8 Participants
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All fatal TRAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All SAEs	4 Participants	4 Participants	3 Participants	6 Participants	4 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to approximately 35 days

Population: Phase 1b DLT Evaluable Analysis Set: All participants who received all planned dose of carfilzomib and the chemotherapy backbone per protocol during the lead-in window and induction cycle, or received at least one dose of carfilzomib and the chemotherapy backbone per protocol and experienced a DLT prior to completion of the lead-in window or induction cycle, or as clinically indicated.

A DLT was defined as any of the following toxicities assessed by the investigator as possibly, probably, or definitely attributable to carfilzomib, with protocol defined exclusions: Any Grade 4 nonhematologic toxicity, ≥ Grade 4 neutropenia or ≥ Grade 3 thrombocytopenia.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=2 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=8 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Haemolytic uraemic syndrome	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Platelet count decreased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Pulmonary haemorrhage	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [Day 36 to Day 50 for infants])

Population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.

CR was defined as: 1. Attainment of M1 bone marrow status (less than 5% blasts in a bone marrow aspirate and at least 200 cells counted) with no evidence of circulating blasts or extramedullary disease. 2. Recovery of peripheral counts: * Absolute neutrophil count (ANC) greater than or equal to 1000/µL * Platelet count greater than or equal to 100000/µL. * Assessed between days 29 and 45 Data was adjusted as inverse probability of treatment weight (IPTW) for the average treatment effect of the treated (IPTW-ATTW).

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants With Complete Remission (CR) After Induction Therapy	14.8 Percentage of Participants Interval 5.9 to 23.7	13.6 Percentage of Participants Interval 3.5 to 23.8	—	—	—	—

SECONDARY outcome

Timeframe: Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15 minutes (m) after the start of infusion, immediately (within 2m) before the end of infusion (EOI), EOI, 10m, 30m, 1 hour (h), 2 h, and 4h post-dose

Population: Phase 1b PK Analysis Set: All participants who received the study treatment regimen during the lead-in cycle and induction cycles, and had available data. Phase 1b Dose Escalation 2 arms did not have a 1-week lead-in cycle.

The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=6 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=6 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=9 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Maximum Concentration (Cmax) of Carfilzomib Alone and in Combination Dose Escalation 1 - Lead in Cycle Day 1	927 ng/mL Standard Deviation 259	637 ng/mL Standard Deviation 241	—	—	—	—
Phase 1b: Maximum Concentration (Cmax) of Carfilzomib Alone and in Combination Induction cycle Day 8	771 ng/mL Standard Deviation 151	792 ng/mL Standard Deviation 580	445 ng/mL Standard Deviation 260	1070 ng/mL Standard Deviation 359	1630 ng/mL Standard Deviation 875	11200 ng/mL Standard Deviation 16400

SECONDARY outcome

Timeframe: Lead-in Cycle Day 1 (7-day cycle) and Induction Cycle Day 8 (28-day cycle): pre-dose, 15m after the start of infusion, immediately (within 2m) before the EOI, EOI, 10m, 30m, 1h, 2 h, and 4h post-dose

The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=6 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=6 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=9 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Area Under the Curve (AUC) From Time 0 to the Last Quantifiable Timepoint (AUClast) of Carfilzomib Dose Escalation 1 - Lead in Cycle Day 1	387 hr*ng/mL Standard Deviation 125	240 hr*ng/mL Standard Deviation 113	—	—	—	—
Phase 1b: Area Under the Curve (AUC) From Time 0 to the Last Quantifiable Timepoint (AUClast) of Carfilzomib Induction Cycle Day 8	361 hr*ng/mL Standard Deviation 160	374 hr*ng/mL Standard Deviation 273	214 hr*ng/mL Standard Deviation 155	529 hr*ng/mL Standard Deviation 210	829 hr*ng/mL Standard Deviation 479	4000 hr*ng/mL Standard Deviation 6370

SECONDARY outcome

The PK parameter estimates for carfilzomib were estimated from plasma concentration-time profiles using standard noncompartmental approaches over the complete sampling interval.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=1 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib Dose Escalation 1 - Lead in Cycle Day 1	387 hr*ng/ mL Standard Deviation 124	268 hr*ng/ mL Standard Deviation 101	—	—	—	—
Phase 1b: AUC From Time 0 to Infinity (AUCinf) of Carfilzomib Induction Cycle Day 8	368 hr*ng/ mL Standard Deviation 184	374 hr*ng/ mL Standard Deviation 273	406 hr*ng/ mL Standard Deviation 0.0	565 hr*ng/ mL Standard Deviation 243	848 hr*ng/ mL Standard Deviation 510	1300 hr*ng/ mL Standard Deviation 1440

SECONDARY outcome

Timeframe: Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day 29)

Population: Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.

CR was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC \> 750 mcl and platelet count \> 75,000 mcl). CRp was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of ANCs (ANC \> 750 mcl), but with insufficient recovery of platelets (\< 75,000 mcl).

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=7 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=10 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Percentage of Participants Who Achieved a Combined CR and CR Without Platelet Recovery (CRp) at the End of Induction Cycle	40.0 Percentage of participants Interval 5.3 to 85.3	20.0 Percentage of participants Interval 0.5 to 71.6	33.3 Percentage of participants Interval 0.8 to 90.6	28.6 Percentage of participants Interval 3.7 to 71.0	25.0 Percentage of participants Interval 0.6 to 80.6	20.0 Percentage of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day29)

Population: Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.

MRD was defined as the quantification of residual lymphoblast in the blood. Assessed by next generation sequencing (NGS).

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=5 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=7 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) n=4 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=10 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle Achieved MRD status < 10^3 lymphoblasts	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status	14.3 Percentage of Participants Interval 0.4 to 57.9	25.0 Percentage of Participants Interval 0.6 to 80.6	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status
Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle Achieved MRD status < 10^4 lymphoblasts	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status	14.3 Percentage of Participants Interval 0.4 to 57.9	25.0 Percentage of Participants Interval 0.6 to 80.6	0 Percentage of Participants Dispersion was not estimable as 0 participants achieved MRD status

SECONDARY outcome

Timeframe: From first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks

Population: Phase 2 Safety Analysis Set: All participants enrolled to study 20140106 who received at least 1 dose of carfilzomib.

An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are AEs that occurred after the start of study treatment and up to the end of the study or 30 days of the last study treatment, whichever is earlier. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. TRAEs were TEAEs considered related to at least one study drug by the investigator, including those with unknown relationship. An SAE was defined as any untoward medical occurrence that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Number of Participants Who Experienced TEAEs Fatal TRAEs	5 Participants	1 Participants	—	—	—	—
Phase 2: Number of Participants Who Experienced TEAEs TEAEs	61 Participants	44 Participants	—	—	—	—
Phase 2: Number of Participants Who Experienced TEAEs SAEs	44 Participants	31 Participants	—	—	—	—
Phase 2: Number of Participants Who Experienced TEAEs Fatal TEAEs	15 Participants	3 Participants	—	—	—	—
Phase 2: Number of Participants Who Experienced TEAEs TRAEs	50 Participants	39 Participants	—	—	—	—
Phase 2: Number of Participants Who Experienced TEAEs Serious TRAEs	25 Participants	24 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])

Population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.

CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. ANC and platelet counts not fulfilling criteria for CR with partial hematologic recovery (CRh), CR without platelet recovery (CRp), or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count \< 100 000/µL. CRh was defined as: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL. Data was IPTW adjusted.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status	42.6 Percentage of Participants Interval 30.2 to 55.0	27.3 Percentage of Participants Interval 14.1 to 40.4	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.

EFS was defined as time from initiation of therapy until treatment failure (defined as failure to reach at least a CRi after consolidation or after induction in participants that did not receive consolidation), relapse, or death from any cause. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR. Data was IPTW adjusted. Medians were estimated using the Kaplan-Meier (KM) method.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Event Free Survival (EFS)	1.18 Months Interval 0.95 to 2.24	1.20 Months Interval 0.95 to 1.48	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.

OS was defined as time from initiation of therapy until death from any cause. Data was IPTW adjusted. Medians were estimated using the KM method.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Overall Survival (OS)	5.23 Months Interval 2.93 to 9.24	4.51 Months Interval 3.49 to 9.18	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. Only participants who achieved CRi or a better remission status were included in the analysis. Data was IPTW adjusted. Medians were estimated using the KM method.

DOR was defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause. CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp) or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count \< 100 000/µL. CRh was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=26 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=14 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Duration of Remission (DOR)	7.55 Months Interval 3.42 to 22.2	9.01 Months Interval 2.57 to Upper CI limit not evaluable due to insufficient observations occurring above the median.	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])

Population: Phase 2 Induction Safety Analysis Set: All participants who started the induction cycle and received at least 1 dose of carfilzomib during the induction period.

MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with next generation sequencing (NGS).

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CR After Induction Therapy Percentage of Participants Achieving MRD <10-³ Cells	8.2 Percentage of Participants Interval 2.7 to 18.1	4.5 Percentage of Participants Interval 0.6 to 15.5	—	—	—	—
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CR After Induction Therapy Percentage of Participants Achieving MRD <10-⁴ Cells	3.3 Percentage of Participants Interval 0.4 to 11.3	4.5 Percentage of Participants Interval 0.6 to 15.5	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])

Population: Phase 2 Induction Safety Analysis Set: All participants who started the induction cycle and received at least 1 dose of carfilzomib during the induction period.

MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Induction Therapy Percentage of Participants Achieving MRD <10-³ Cells	18.0 Percentage of Participants Interval 9.4 to 30.0	9.1 Percentage of Participants Interval 2.5 to 21.7	—	—	—	—
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Induction Therapy Percentage of Participants Achieving MRD <10-⁴ Cells	9.8 Percentage of Participants Interval 3.7 to 20.2	6.8 Percentage of Participants Interval 1.4 to 18.7	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])

Population: Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period.

MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=25 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=20 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy Percentage of Participants Achieving MRD <10-³ Cells	16.0 Percentage of Participants Interval 4.5 to 36.1	20.0 Percentage of Participants Interval 5.7 to 43.7	—	—	—	—
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy Percentage of Participants Achieving MRD <10-⁴ Cells	16.0 Percentage of Participants Interval 4.5 to 36.1	20.0 Percentage of Participants Interval 5.7 to 43.7	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 2 years

Population: Phase 2: Safety analysis set: All participants who received at least 1 dose of carfilzomib.

Percentage of participants who successfully underwent stem cell transplant or CAR-T therapy without experiencing a relapse after receiving the protocol-specified treatment.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=61 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=44 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants Who Underwent Stem Cell Transplant or Chimeric Antigen Receptor T-cell (CAR-T) Without Intervening Relapse Following Protocol-Specified Therapy	19.7 Percentage of Participants Interval 10.6 to 31.8	27.3 Percentage of Participants Interval 15.0 to 42.8	—	—	—	—

SECONDARY outcome

Population: Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period.

CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ to 1000/µL ii. Platelet count \< 100 000/µL. CRh was defined as: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL. Data was IPTW adjusted.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=25 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=20 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Percentage of Participants With CRi or Better Remission Status After Consolidation Therapy	36.0 Percentage of Participants Interval 18.0 to 57.5	50.0 Percentage of Participants Interval 27.2 to 72.8	—	—	—	—

SECONDARY outcome

Timeframe: Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)

Population: Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.

AUClast refers to the total exposure of a drug in the body over time, calculated from the time of administration until the last measurable concentration in the blood.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=83 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=34 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: AUClast of Carfilzomib	4330 hr*ng/mL Standard Deviation 10300	9410 hr*ng/mL Standard Deviation 36200	—	—	—	—

SECONDARY outcome

Timeframe: Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)

AUCinf represents the total drug exposure over time, extrapolated from the time of administration until the drug is completely eliminated from the body.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=46 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=23 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: AUCinf of Carfilzomib	4070 hr*ng/mL Standard Deviation 11000	1200 hr*ng/mL Standard Deviation 2480	—	—	—	—

SECONDARY outcome

Timeframe: Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)

Cmax is the maximum concentration of a drug in the bloodstream after administration.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=83 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=34 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Cmax of Carfilzomib	9590 ng/mL Standard Deviation 27800	13800 ng/mL Standard Deviation 44200	—	—	—	—

SECONDARY outcome

Timeframe: Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)

T1/2,z refers to the time required for the plasma concentration of a drug to decrease by half during the final phase of elimination from the body.

Outcome measures

Outcome measures
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=46 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=23 Participants Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 2: Terminal Half-life (t1/2,z) of Carfilzomib	0.371 hour Standard Deviation 0.162	0.332 hour Standard Deviation 0.0894	—	—	—	—

Adverse Events

Phase 1b: Dose Escalation 1 (20 mg/m^2)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Phase 1b: Dose Escalation 1 (20/27 mg/m^2)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase 1b: Dose Escalation 2 (20/27 mg/m^2)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1b: Dose Escalation 2 (20/36 mg/m^2)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 0 deaths

Phase 1b: Dose Escalation 2 (20/45 mg/m^2

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 1b: Dose Escalation 2 (20/56 mg/m^2)

Serious events: 7 serious events

Other events: 9 other events

Deaths: 3 deaths

Phase 2: B-cell (20/56 mg/m^2)

Serious events: 44 serious events

Other events: 61 other events

Deaths: 41 deaths

Phase 2: T-cell (20/56 mg/m^2)

Serious events: 31 serious events

Other events: 43 other events

Deaths: 29 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=6 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=7 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2 n=4 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=10 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 2: B-cell (20/56 mg/m^2) n=61 participants at risk Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	Phase 2: T-cell (20/56 mg/m^2) n=44 participants at risk Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Febrile neutropenia	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	13.1% 8/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Angina pectoris	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Cardiac dysfunction	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Tachycardia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Toxic cardiomyopathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Colitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Malaise	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Multiple organ dysfunction syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Pyrexia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Hepatitis acute	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Alpha haemolytic streptococcal infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Appendicitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bacteraemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bacterial infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bacterial sepsis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations COVID-19	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations COVID-19 pneumonia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Device related infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Encephalitis	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Escherichia sepsis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Fungaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Fungal infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Herpes simplex reactivation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Lower respiratory tract infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Meningitis bacterial	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Necrotising fasciitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Neutropenic sepsis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pneumonia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pneumonia fungal	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pneumonia klebsiella	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pseudomonal sepsis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Sepsis	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Sepsis syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Septic shock	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.8% 9/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Severe acute respiratory syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Soft tissue infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Vascular device infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Viral infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Blood creatinine increased	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Body temperature increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Neutrophil count decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Oxygen saturation decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Cerebral haemorrhage	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Cerebral small vessel ischaemic disease	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Cerebrovascular accident	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Cerebrovascular disorder	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Cognitive disorder	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Consciousness fluctuating	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Encephalopathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Nervous system disorder	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Petit mal epilepsy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Seizure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Toxic encephalopathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Acute kidney injury	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Haematuria	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Mediastinal disorder	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary veno-occlusive disease	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Hypotension	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Hypovolaemic shock	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Jugular vein thrombosis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Enterocolitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Mucosal inflammation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Hepatic failure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Immune system disorders Drug hypersensitivity	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bacillus bacteraemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Fusobacterium infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Infection in an immunocompromised host	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pneumonia viral	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Stomatococcal infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Systemic candida	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Catheter culture positive	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Platelet count decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Brain oedema	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Clonic convulsion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Dysarthria	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Hydrocephalus	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Neuralgia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Somnolence	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Confusional state	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.

Other adverse events

Other adverse events
Measure	Phase 1b: Dose Escalation 1 (20 mg/m^2) n=5 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 1 (20/27 mg/m^2) n=6 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/27 mg/m^2) n=3 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/36 mg/m^2) n=7 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/45 mg/m^2 n=4 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 1b: Dose Escalation 2 (20/56 mg/m^2) n=10 participants at risk Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).	Phase 2: B-cell (20/56 mg/m^2) n=61 participants at risk Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.	Phase 2: T-cell (20/56 mg/m^2) n=44 participants at risk Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Nervous system disorders Lethargy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Loss of consciousness	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Paraesthesia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Neuralgia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Seizure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Somnolence	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Syncope	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Abnormal behaviour	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Affective disorder	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Agitation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Anxiety	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Depression	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Insomnia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Irritability	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Psychiatric disorders Suicidal ideation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Chromaturia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Proteinuria	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Renal failure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Urinary incontinence	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Reproductive system and breast disorders Breast pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Dry throat	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Sinusitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Mucosal inflammation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Septic shock	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Anaemia	80.0% 4/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	83.3% 5/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	66.7% 2/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	57.1% 4/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	75.0% 3/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	60.7% 37/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	52.3% 23/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	27.9% 17/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 11/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	19.7% 12/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	22.7% 10/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Lymphopenia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.8% 6/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Neutropenia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	39.3% 24/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	38.6% 17/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Thrombocytopenia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	37.7% 23/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	45.5% 20/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Tachycardia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	75.0% 3/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.8% 9/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	15.9% 7/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Constipation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.5% 7/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.5% 9/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Diarrhoea	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	57.1% 4/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	21.3% 13/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.5% 9/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Nausea	80.0% 4/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	66.7% 2/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	71.4% 5/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	13.1% 8/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 11/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Oral pain	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	15.9% 7/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Vomiting	80.0% 4/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	75.0% 3/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.5% 7/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	15.9% 7/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Face oedema	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	15.9% 7/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Pyrexia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	66.7% 4/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	66.7% 2/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	44.3% 27/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	52.3% 23/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bacteraemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations COVID-19	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pneumonia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Rhinovirus infection	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Sepsis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Alanine aminotransferase increased	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	34.4% 21/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	31.8% 14/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Antithrombin III decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.4% 5/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Aspartate aminotransferase increased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	29.5% 18/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	22.7% 10/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Blood bilirubin increased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.8% 6/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Gamma-glutamyltransferase increased	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.5% 7/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.4% 5/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations International normalised ratio increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Lymphocyte count decreased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Neutrophil count decreased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.8% 6/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Platelet count decreased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	40.0% 4/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	18.0% 11/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations White blood cell count decreased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	18.0% 11/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.4% 5/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyperglycaemia	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	13.6% 6/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyperkalaemia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypertriglyceridaemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	13.1% 8/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypoalbuminaemia	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	29.5% 18/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	18.2% 8/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypocalcaemia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	18.0% 11/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.4% 5/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypoglycaemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypokalaemia	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	24.6% 15/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	38.6% 17/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypomagnesaemia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.4% 5/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyponatraemia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.8% 6/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypophosphataemia	60.0% 3/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	11.4% 5/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Arthralgia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	66.7% 2/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Pain in extremity	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	57.1% 4/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Headache	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	42.9% 3/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	13.1% 8/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	22.7% 10/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Acute kidney injury	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Renal and urinary disorders Haematuria	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Cough	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Epistaxis	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	8.2% 5/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.8% 3/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	6.6% 4/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Hypertension	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 3/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	85.7% 6/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	70.0% 7/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	41.0% 25/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	29.5% 13/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Hypotension	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	75.0% 3/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	20.0% 2/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	9.1% 4/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Atrioventricular block	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Bradycardia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Cardiac failure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Sinus bradycardia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Cardiac disorders Sinus tachycardia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Endocrine disorders Adrenal insufficiency	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Endocrine disorders Cushingoid	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Diplopia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Dry eye	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Eye irritation	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Eye pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Periorbital oedema	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Periorbital swelling	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Photophobia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	66.7% 2/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Eye disorders Vision blurred	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Anal fissure	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Colitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Dental caries	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Lip dry	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Oral mucosal erythema	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Toothache	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Catheter site erythema	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Catheter site pain	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Chills	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Fatigue	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	50.0% 2/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Influenza like illness	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Multiple organ dysfunction syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Oedema	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Oedema peripheral	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
General disorders Peripheral swelling	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Cholangitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Cholecystitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Hepatobiliary disorders Hepatic lesion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Immune system disorders Drug hypersensitivity	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Immune system disorders Hypersensitivity	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Immune system disorders Immunodeficiency common variable	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Appendicitis perforated	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Aspergillus infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Pseudomembranous colitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Bacterial infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Cytomegalovirus infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Device related bacteraemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Device related infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Enterocolitis infectious	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Fungal sepsis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Infection in an immunocompromised host	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Oral candidiasis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Oral herpes	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Paronychia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Stomatococcal infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Varicella zoster virus infection	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Infections and infestations Viral upper respiratory tract infection	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Foreign body ingestion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Injury, poisoning and procedural complications Scratch	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Activated partial thromboplastin time prolonged	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Ammonia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Amylase increased	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Aspartate aminotransferase decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Bacterial test positive	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Bilirubin conjugated increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Blood creatine increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Blood creatinine increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Blood fibrinogen decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Blood urea increased	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Breath sounds abnormal	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations C-reactive protein increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Candida test positive	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Electrocardiogram QT prolonged	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Immunoglobulins decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Lipase increased	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Lymphocyte count	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Protein total abnormal	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Staphylococcus test positive	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Urine protein/creatinine ratio increased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Weight decreased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 2/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Investigations Weight increased	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Acidosis	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Decreased appetite	80.0% 4/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Fluid overload	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypercalcaemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypermagnesaemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hypernatraemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Hyperphosphataemia	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.9% 3/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Joint swelling	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Musculoskeletal and connective tissue disorders Pain in jaw	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	3.3% 2/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Dizziness	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Nervous system disorders Epilepsy	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Respiratory, thoracic and mediastinal disorders Tachypnoea	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Alopecia	40.0% 2/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	4.5% 2/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Papule	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	30.0% 3/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	33.3% 1/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	25.0% 1/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Purpura	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	28.6% 2/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	16.7% 1/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	1.6% 1/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Flushing	20.0% 1/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Haematoma	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	14.3% 1/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	2.3% 1/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.
Vascular disorders Thrombophlebitis	0.00% 0/5 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/6 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/3 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/7 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/4 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	10.0% 1/10 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/61 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.	0.00% 0/44 • Phase 1b/2: For deaths, up to approximately 2 years. For TEAEs, from first dose up to 30 days after the last dose of study treatment; maximum duration of treatment was 8 weeks Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER