Trial Outcomes & Findings for CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors (NCT NCT02401815)

Last Updated: 2025-02-14

Results Overview

RP2D was determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) V4.03. DLTs: AEs that occurred during Cycle 1, possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for \>7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for \>7 days, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Cycle 1 of Part 1 (Cycle length = 28 days)

Results posted on

2025-02-14

Participant Flow

This study included a dose escalation portion (Part 1) in which the safety profile and recommended phase 2 dose (RP2D) of CGT9486 as a single oral agent was evaluated in participants with solid tumors (including gastrointestinal stromal tumor \[GIST\]), followed by signal-seeking extension cohorts of CGT9486 in combination with pexidartinib or sunitinib (Part 2). Parts 2a, 2c, 2d, and 2f were not conducted due to business decisions.

A total of 51 participants were enrolled; 24 participants were enrolled across 5 cohorts in Part 1, 12 participants were enrolled across 2 cohorts in Part 2b, and 18 participants (including 3 "re-enrolled") were enrolled across 3 cohorts in Part 2e. 1 participant enrolled in Part 1 and 2 participants enrolled in Part 2b and subsequently were re-enrolled in Part 2e with new identification numbers unique to Part 2e. Participant numbers were not reassigned or reused.

Participant milestones

Participant milestones
Measure	Part 1: CGT9486 250 mg QD Participants received CGT9486 250 milligrams (mg) orally once daily (QD) in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg QD Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally twice daily (BID) in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Fasting) Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Non-Fasting) Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Dose Escalation (up to 670 Days) STARTED	3	4	3	7	7	0	0	0	0	0
Dose Escalation (up to 670 Days) Received at Least 1 Dose of Study Drug	3	4	3	7	7	0	0	0	0	0
Dose Escalation (up to 670 Days) COMPLETED	0	0	0	0	0	0	0	0	0	0
Dose Escalation (up to 670 Days) NOT COMPLETED	3	4	3	7	7	0	0	0	0	0
Dose Extension Part 2b (up to 868 Days) STARTED	0	0	0	0	0	4	8	0	0	0
Dose Extension Part 2b (up to 868 Days) Received at Least 1 Dose of Study Drug	0	0	0	0	0	4	8	0	0	0
Dose Extension Part 2b (up to 868 Days) COMPLETED	0	0	0	0	0	0	0	0	0	0
Dose Extension Part 2b (up to 868 Days) NOT COMPLETED	0	0	0	0	0	4	8	0	0	0
Dose Extension Part 2e (up to 868 Days) STARTED	0	0	0	0	0	0	0	3	5	10
Dose Extension Part 2e (up to 868 Days) Received at Least 1 Dose of Study Drug	0	0	0	0	0	0	0	3	5	10
Dose Extension Part 2e (up to 868 Days) COMPLETED	0	0	0	0	0	0	0	0	0	0
Dose Extension Part 2e (up to 868 Days) NOT COMPLETED	0	0	0	0	0	0	0	3	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: CGT9486 250 mg QD Participants received CGT9486 250 milligrams (mg) orally once daily (QD) in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg QD Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally twice daily (BID) in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Fasting) Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Non-Fasting) Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Dose Escalation (up to 670 Days) Adverse Event	0	0	0	1	0	0	0	0	0	0
Dose Escalation (up to 670 Days) Clinical Progression	1	0	0	1	0	0	0	0	0	0
Dose Escalation (up to 670 Days) Death	1	2	3	5	4	0	0	0	0	0
Dose Escalation (up to 670 Days) Progressive Disease (Per RECIST)	0	2	0	0	2	0	0	0	0	0
Dose Escalation (up to 670 Days) Withdrawal by Subject	1	0	0	0	1	0	0	0	0	0
Dose Extension Part 2b (up to 868 Days) Death	0	0	0	0	0	2	0	0	0	0
Dose Extension Part 2b (up to 868 Days) Progressive Disease (Per RECIST)	0	0	0	0	0	0	5	0	0	0
Dose Extension Part 2b (up to 868 Days) Withdrawal by Subject	0	0	0	0	0	1	3	0	0	0
Dose Extension Part 2b (up to 868 Days) Other than specified	0	0	0	0	0	1	0	0	0	0
Dose Extension Part 2e (up to 868 Days) Death	0	0	0	0	0	0	0	1	2	4
Dose Extension Part 2e (up to 868 Days) Progressive Disease (Per RECIST)	0	0	0	0	0	0	0	0	2	1
Dose Extension Part 2e (up to 868 Days) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	2
Dose Extension Part 2e (up to 868 Days) Clinical Progression	0	0	0	0	0	0	0	0	1	0
Dose Extension Part 2e (up to 868 Days) Other than specified	0	0	0	0	0	0	0	2	0	3

Baseline Characteristics

CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: CGT9486 (Single-Agent) n=24 Participants Participants received doses of CGT9486 ranging from 250 to 1000 mg/day orally in 5 sequential dose escalation cohorts (CGT9486 250 mg QD, 350 mg QD, 500 mg QD, 1000 mg QD, and 500 mg BID). Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg n=12 Participants Participants received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 + Sunitinib n=15 Participants Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally, CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally, or CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally; in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Total n=51 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 11.91 • n=5 Participants	64.4 years STANDARD_DEVIATION 10.43 • n=7 Participants	60.1 years STANDARD_DEVIATION 9.41 • n=5 Participants	60.1 years STANDARD_DEVIATION 10.98 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	31 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	48 Participants n=4 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
Race (NIH/OMB) 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
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	42 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (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

PRIMARY outcome

Timeframe: Cycle 1 of Part 1 (Cycle length = 28 days)

Population: Safety population included all participants treated with at least 1 dose of any study drug.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=24 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Recommended Phase 2 Dose (RP2D) of CGT9486	—	1000 mg	—	—	—

PRIMARY outcome

Timeframe: From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days)

Population: Safety population included all participants treated with at least 1 dose of any study drug.

An adverse event (AE) was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A treatment-emergent AE (TEAE) was an AE that started or worsened in severity on or after the date of the initial dose of study drug. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=4 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	4 Participants	3 Participants	3 Participants	7 Participants	7 Participants

PRIMARY outcome

Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15

Population: PK population included all participants who had adequate PK data. Here, 'number analyzed signifies participants evaluable at specified timepoints.

AUC0-24 was determined by the linear trapezoidal rule for the ascending portion and by the log trapezoidal rule for the descending portion of the plasma profile. For BID dosing, Cycle 1 Day 15 AUC0-24 was calculated as 2 x area under the concentration time curve from time zero to 12 hours after dosing (AUC0-12). Missing concentration data were excluded from Pharmacokinetic (PK) analysis.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=4 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Area Under The Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24) of CGT9486 Cycle 1, Day 1	7200 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 20.7	9240 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 8.7	5980 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 41.7	11000 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 26.3	NA nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation NA AUC(0-24) on Cycle 1 Day 1 cannot be determined from the 500 mg BID group due to BID dosing (2nd dose given 12 hours after the 1st dose) and limitation of sampling schedule (sampling up to 9 hours after the 1st dose and no samples collected after the 2nd dose).
Part 1: Area Under The Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24) of CGT9486 Cycle 1, Day 15	21300 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 27.7	18500 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 43.7	15400 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 65.8	22100 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 56	24800 nanograms (ng)*hour/milliliter (mL) Geometric Coefficient of Variation 51.4

PRIMARY outcome

Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15

Population: PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.

Cmax was taken directly from bioanalytical data.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=4 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Maximum Observed Plasma Concentration (Cmax) of CGT9486 Cycle 1, Day 1	332 ng/mL Geometric Coefficient of Variation 17.9	499 ng/mL Geometric Coefficient of Variation 6.92	382 ng/mL Geometric Coefficient of Variation 6.48	558 ng/mL Geometric Coefficient of Variation 28.1	331 ng/mL Geometric Coefficient of Variation 22.8
Part 1: Maximum Observed Plasma Concentration (Cmax) of CGT9486 Cycle 1, Day 15	1010 ng/mL Geometric Coefficient of Variation 27.5	869 ng/mL Geometric Coefficient of Variation 38.4	714 ng/mL Geometric Coefficient of Variation 64.9	1060 ng/mL Geometric Coefficient of Variation 59	1150 ng/mL Geometric Coefficient of Variation 52.4

PRIMARY outcome

Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 (Day -10 for 350 mg QD cohort) and Cycle 1 Day 15

Population: PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.

Tmax was taken directly from merged clinical and bioanalytical data, with time presented as nominal time relative to dose.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=4 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Time to Reach Cmax (Tmax) of CGT9486 Cycle 1, Day 15	9 hours Interval 0.0 to 9.0	3 hours Interval 1.0 to 24.0	7 hours Interval 7.0 to 24.0	6 hours Interval 3.0 to 24.0	5 hours Interval 1.0 to 9.0
Part 1: Time to Reach Cmax (Tmax) of CGT9486 Cycle 1, Day 1 (or Day -10)	16.5 hours Interval 9.0 to 24.0	9 hours Interval 9.0 to 24.0	15 hours Interval 6.0 to 24.0	9 hours Interval 3.0 to 24.0	7 hours Interval 3.0 to 9.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 2, 4, 9, 24, 49, 72, 96, 120, 144, 168, 192, 216 hours postdose on Day -10

Population: Half life of PLX9486 can only be determined in participants who participated in the PK substudy. Sampling schedule in other Part 1 and Part 2 cohorts do not allow for determination of t1/2.

Participants in a selected Part 1 cohort (350 mg QD) participated in a PK substudy to obtain more complete information on the PK profile of PLX9486. Participants received a single dose of 350 mg of PLX9486 10 days prior to the start of repeated QD dosing and plasma concentrations were followed 0.5, 1, 2, 4, 6, and 9 hours postdose, and then once daily for 9 additional days prior to Cycle 1 Day 1.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=4 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Half Life (T1/2) of PLX9486	—	75.4 hours Standard Deviation 26.1	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 of Part 2e (Cycle length = 28 days)

Population: Safety population included all participants treated with at least 1 dose of any study drug.

RP2D was determined by incidence of DLT using CTCAE version 4.03 for severity grade. DLTs were defined as AEs that occurred during Cycle 1, classified as possibly/probably related to study drug, and met 1 of the following criteria: Hematologic Toxicities: Grade 4 neutropenia for \>7 days, Grade ≥3 neutropenia with fever, Grade 4 thrombocytopenia, Grade ≥3 thrombocytopenia for \>7 days or with bleeding, Grade 4 anemia; Other Toxicities: Any Grade ≥3 (AE or laboratory) toxicity despite adequate supportive care except for the following: Grade ≥3 nausea, vomiting, or diarrhea that resolved to Grade ≤2 within 72 hours; Grade 3 fatigue that resolved to Grade ≤2 within 14 days; Grade ≥3 asymptomatic changes in alkaline phosphatase, hypomagnesemia, hyperglycemia, or hypophosphatemia; Grade 3 increases in transaminases for ≤5 days; Any other Grade ≥3 toxicity for which further dose escalation deemed inappropriate.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=18 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2e: RP2D of CGT9486 in Combination With Sunitinib	—	1000 mg	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 of Part 2 b (Cycle length = 28 days)

Population: Safety population included all participants treated with at least 1 dose of any study drug.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=4 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2b: RP2D of PLX9486 in Combination With Pexidartinib	NA mg NA signifies RP2D was not estimable due to no DLTs were experienced during Part 2b.	NA mg NA signifies RP2D was not estimable due to no DLTs were experienced during Part 2b.	—	—	—

PRIMARY outcome

Timeframe: From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 868 days)

Population: Safety population included all participants treated with at least 1 dose of any study drug.

An AE was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE could be any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that had increased in severity or frequency since the administration of study drug. A TEAE was an AE that started or worsened in severity on or after the date of the initial dose of study drug. Treatment-related TEAEs included all events reported as "possibly related" or "probably related" to any of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=4 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2b: Number of Participants With Any TEAEs and Treatment-Related TEAEs TEAEs	8 Participants	4 Participants	—	—	—
Part 2b: Number of Participants With Any TEAEs and Treatment-Related TEAEs Related TEAEs	7 Participants	4 Participants	—	—	—

PRIMARY outcome

Timeframe: From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 825 days)

Population: Safety population included all participants treated with at least 1 dose of any study drug.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=5 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=10 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2e: Number of Participants With Any TEAEs and Treatment-Related TEAEs TEAEs	5 Participants	3 Participants	10 Participants	—	—
Part 2e: Number of Participants With Any TEAEs and Treatment-Related TEAEs Related TEAEs	5 Participants	3 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: From the date of first dose of study drug until the first appearance of CR or PR (maximum exposure: 670 days)

ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=4 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=6 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Overall Response Rate (ORR): Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed Using RECIST V1.1	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 70.8	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: From the first date of treatment until the first documented disease progression or date of death (maximum exposure: 670 days)

PFS was defined as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of the first documented disease progression or date of death, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=4 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=6 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Progression-Free Survival (PFS), as Assessed Using RECIST V1.1	53 days Interval 20.0 to 53.0	54 days Interval 28.0 to 56.0	48 days Interval 47.0 to 221.0	144 days Interval 38.0 to 335.0	186 days Interval 20.0 to 669.0

SECONDARY outcome

Timeframe: From the date of first response (PR or CR) to the date of first documented disease progression/relapse or death, whichever occurred first (maximum exposure: 670 days)

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Here, 'Overall number of participants analyzed' signifies participants with best overall response of CR or PR.

DOR was defined as the number of days from the date of first response (PR or CR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression. Median was calculated using Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=1 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 1: Duration of Response (DOR), as Assessed Using RECIST V1.1	—	—	—	224 days	—

SECONDARY outcome

Timeframe: From the date of first dose of study drug until the first appearance of CR or PR (maximum exposure: 868 days)

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.

ORR was defined as the percentage of participants who achieved a best overall response of confirmed CR or PR. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Overall Response Rate (ORR): Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed Using RECIST V1.1	0 percentage of participants Interval 0.0 to 36.9	33.3 percentage of participants Interval 0.8 to 90.6	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 52.2	28.6 percentage of participants Interval 3.7 to 71.0

SECONDARY outcome

Timeframe: From the date of first dose of study drug until the first appearance of CR, PR, or SD (maximum exposure: 868 days)

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.

Participants were considered to experience clinical benefit if they had a best overall response of stable disease (SD) that lasted for at least 16 weeks, or confirmed best overall response of PR or CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters. CR: Disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (target or non-target) must had reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit, as Assessed Using RECIST V1.1	37.5 percentage of participants Interval 8.5 to 75.5	100 percentage of participants Interval 29.2 to 100.0	100 percentage of participants Interval 29.2 to 100.0	60.0 percentage of participants Interval 14.7 to 94.7	85.7 percentage of participants Interval 42.1 to 99.6

SECONDARY outcome

Timeframe: From the first date of treatment until the first documented disease progression or date of death (maximum exposure: 868 days)

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Progression-Free Survival (PFS), as Assessed Using RECIST V1.1	128 days Interval 26.0 to 867.0	333 days Interval 234.0 to 336.0	NA days Interval 503.0 to Due to smaller number of participants with an event, Median and upper limit of 95% confidence interval (CI) could not be calculated.	319 days Interval 26.0 to 530.0	NA days Interval 41.0 to Due to smaller number of participants with an event, Median and upper limit of 95% CI could not be calculated.

SECONDARY outcome

Timeframe: From the first day of treatment until the date of death (maximum exposure: 868 days)

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.

Overall Survival was defined as the number of days from the first day of treatment (Cycle 1 Day 1) until the date of death. If a participant was lost to follow-up, overall survival was censored at the date of last contact. Median was calculated using Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Overall Survival	414 days Interval 106.0 to Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.	853 days Interval 240.0 to 853.0	NA days Interval 551.0 to Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.	362 days Interval 164.0 to Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.	NA days Interval 98.0 to Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.

SECONDARY outcome

Timeframe: Month 12

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.

Percentage of participants who survived at Month 12 have been reported.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Overall Survival at Month 12	55.6 percentage of participants Interval 7.3 to 87.6	66.7 percentage of participants Interval 5.4 to 94.5	100 percentage of participants Interval 100.0 to 100.0	40.0 percentage of participants Interval 5.2 to 75.3	68.6 percentage of participants Interval 21.3 to 91.2

SECONDARY outcome

Timeframe: Month 6

Population: Efficacy evaluable population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline tumor assessment or discontinue study medication early due to disease progression or death. Data for 3 re-enrolled participants is included in their initial cohort analysis but not in the Part 2e analysis.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=3 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: PFS at Month 6	25.0 percentage of participants Interval 1.4 to 63.5	100 percentage of participants Interval 100.0 to 100.0	100 percentage of participants Interval 100.0 to 100.0	60.0 percentage of participants Interval 12.6 to 88.2	85.7 percentage of participants Interval 33.4 to 97.9

SECONDARY outcome

Timeframe: From the date of first response (PR or CR) to the date of first documented disease progression/relapse or death, whichever occurred first (maximum exposure: 868 days)

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=1 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=1 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=2 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Duration of Response (DOR), as Assessed Using RECIST V1.1	—	169 days	NA days Due to smaller number of participants with an event, data could not be calculated.	—	NA days Due to smaller number of participants with an event, data could not be calculated.

SECONDARY outcome

Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15

Population: PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.

AUC0-24 was determined by the linear trapezoidal rule for the ascending portion and by the log trapezoidal rule for the descending portion of the plasma profile. Missing concentration data were excluded from PK analysis.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=4 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=10 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: AUC0-24 of CGT9486 in Combination With Pexidartinib or Sunitinib Cycle 1, Day 1	7910 ng*hour/mL Geometric Coefficient of Variation 21.9	7810 ng*hour/mL Geometric Coefficient of Variation 31.6	9800 ng*hour/mL Geometric Coefficient of Variation 69.4	14800 ng*hour/mL Geometric Coefficient of Variation 16.3	12700 ng*hour/mL Geometric Coefficient of Variation 28.5
Part 2: AUC0-24 of CGT9486 in Combination With Pexidartinib or Sunitinib Cycle 1, Day 15	19100 ng*hour/mL Geometric Coefficient of Variation 32.5	20300 ng*hour/mL Geometric Coefficient of Variation 53.2	26500 ng*hour/mL Geometric Coefficient of Variation 61.3	41400 ng*hour/mL Geometric Coefficient of Variation 28.9	38300 ng*hour/mL Geometric Coefficient of Variation 43.3

SECONDARY outcome

Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15

Population: PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.

Cmax was taken directly from bioanalytical data.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=4 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=10 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Cmax of CGT9486 in Combination With Pexidartinib or Sunitinib Cycle 1, Day 1	412 ng/mL Geometric Coefficient of Variation 26.8	384 ng/mL Geometric Coefficient of Variation 34.4	512 ng/mL Geometric Coefficient of Variation 69.2	866 ng/mL Geometric Coefficient of Variation 10.9	681 ng/mL Geometric Coefficient of Variation 28.1
Part 2: Cmax of CGT9486 in Combination With Pexidartinib or Sunitinib Cycle 1, Day 15	924 ng/mL Geometric Coefficient of Variation 30.7	991 ng/mL Geometric Coefficient of Variation 53.9	1200 ng/mL Geometric Coefficient of Variation 61	2040 ng/mL Geometric Coefficient of Variation 13.7	1850 ng/mL Geometric Coefficient of Variation 42.5

SECONDARY outcome

Timeframe: Predose, 1, 3, 5, 7, 9, and 24 hours postdose at Cycle 1 Day 1 and Cycle 1 Day 15

Population: PK population included all participants who had adequate PK data. Here, 'number analyzed' signifies participants evaluable at specified timepoints.

Tmax was taken directly from merged clinical and bioanalytical data, with time presented as nominal time relative to dose.

Outcome measures

Outcome measures
Measure	Part 1: CGT9486 350 mg QD n=8 Participants Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg n=4 Participants Participants received a single dose of 350 mg of PLX9486 10 days (on Day -10) prior to the start of 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=3 Participants Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=5 Participants Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=10 Participants Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Part 2: Tmax of CGT9486 in Combination With Pexidartinib or Sunitinib Cycle 1, Day 1	9 hours Interval 5.0 to 24.0	8 hours Interval 3.0 to 24.0	9 hours Interval 7.0 to 9.0	24 hours Interval 7.0 to 24.0	9 hours Interval 7.0 to 24.0
Part 2: Tmax of CGT9486 in Combination With Pexidartinib or Sunitinib Cycle 2, Day 15	6 hours Interval 3.0 to 9.0	5 hours Interval 5.0 to 9.0	3 hours Interval 0.0 to 9.0	9 hours Interval 3.0 to 24.0	3 hours Interval 0.0 to 24.0

Adverse Events

Part 1: CGT9486 250 mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Part 1: CGT9486 350 mg QD

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Part 1: CGT9486 500 mg QD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1: CGT9486 1000 mg QD

Serious events: 1 serious events

Other events: 7 other events

Deaths: 5 deaths

Part 1: CGT9486 500 mg BID

Serious events: 3 serious events

Other events: 7 other events

Deaths: 4 deaths

Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Fasting)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Non-Fasting)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg

Serious events: 4 serious events

Other events: 10 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: CGT9486 250 mg QD n=3 participants at risk Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg QD n=4 participants at risk Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg QD n=3 participants at risk Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 participants at risk Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 participants at risk Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Fasting) n=4 participants at risk Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Non-Fasting) n=8 participants at risk Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg n=3 participants at risk Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg n=5 participants at risk Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=10 participants at risk Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Surgical and medical procedures Prophylaxis against dehydration	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Nausea	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Urinary tract infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Melaena	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Abdominal abscess	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Pneumonia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Sepsis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.

Other adverse events

Other adverse events
Measure	Part 1: CGT9486 250 mg QD n=3 participants at risk Participants received CGT9486 250 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 350 mg QD n=4 participants at risk Participants received CGT9486 350 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg QD n=3 participants at risk Participants received CGT9486 500 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 1000 mg QD n=7 participants at risk Participants received CGT9486 1000 mg orally QD in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 1: CGT9486 500 mg BID n=7 participants at risk Participants received CGT9486 500 mg orally BID in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Fasting) n=4 participants at risk Participants in fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2b: CGT9486 500 mg QD + Pexidartinib 600 mg (Non-Fasting) n=8 participants at risk Participants in non-fasting condition received CGT9486 500 mg orally QD in combination with pexidartinib 600 mg (administered as 1 capsule of 200 mg in the morning and 2 capsules of 200 mg in the evening) orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 500 mg QD + Sunitinib 25 mg n=3 participants at risk Participants received CGT9486 500 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 25 mg n=5 participants at risk Participants received CGT9486 1000 mg orally QD in combination with sunitinib 25 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.	Part 2e: CGT9486 1000 mg QD + Sunitinib 37.5 mg n=10 participants at risk Participants received CGT9486 1000 mg orally QD in combination with sunitinib 37.5 mg orally in 28-day dosing cycles. Treatment was continued until participant discontinuation, withdrawal, or study termination.
Investigations Blood creatinine increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	57.1% 4/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	37.5% 3/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	100.0% 3/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	80.0% 8/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Nausea	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	37.5% 3/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	100.0% 3/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 5/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Constipation	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	60.0% 3/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Glossodynia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Abnormal faeces	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Ascites	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Eructation	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Faeces discoloured	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Oral pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Salivary gland pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Gastrointestinal disorders Swollen tongue	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 2/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	57.1% 4/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 4/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	70.0% 7/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 5/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 5/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Weight decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	37.5% 3/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	57.1% 4/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood bilirubin increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations White blood cell count decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Weight increased	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood albumin decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood magnesium decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Neutrophil count decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood potassium decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood uric acid increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Platelet count increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations White blood cell count increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood glucose increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Blood phosphorus decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Body temperature increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Breath sounds abnormal	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Ejection fraction decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations International normalised ratio increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Investigations Platelet count decreased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 2/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	100.0% 3/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	60.0% 3/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	60.0% 6/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Fatigue	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	100.0% 4/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	57.1% 4/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	57.1% 4/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 4/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Oedema peripheral	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	37.5% 3/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Pyrexia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Chest discomfort	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Chills	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Asthenia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Chest pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Non-cardiac chest pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Swelling face	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Early satiety	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Face oedema	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Gait disturbance	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Malaise	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Peripheral swelling	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Sensation of foreign body	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
General disorders Temperature intolerance	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 4/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Tinea pedis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Hair disorder	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Yellow skin	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	42.9% 3/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 2/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Headache	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	100.0% 3/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Dysgeusia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Dizziness	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Taste disorder	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Memory impairment	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Balance disorder	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Cognitive disorder	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Disturbance in attention	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Dysarthria	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Hypogeusia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Neuralgia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Paraesthesia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Sciatica	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Nervous system disorders Tremor	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 2/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Influenza	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Pneumonia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Urinary tract infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Fungal skin infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Oral candidiasis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Anorectal infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Bronchitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Cellulitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Conjunctivitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Cystitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Eye infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Fungal infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Gastroenteritis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Hordeolum	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Localised infection	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Rash pustular	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Sinusitis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Infections and infestations Tinea cruris	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Psychiatric disorders Insomnia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 2/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 2/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Psychiatric disorders Depression	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Psychiatric disorders Sleep disorder	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Psychiatric disorders Affect lability	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Psychiatric disorders Delirium	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Vascular disorders Hypertension	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	75.0% 3/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	60.0% 3/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	40.0% 4/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Vascular disorders Flushing	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Vascular disorders Haematoma	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Vascular disorders Hypotension	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Periorbital oedema	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	30.0% 3/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Vision blurred	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	28.6% 2/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Dry eye	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Eye inflammation	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Eyelash discolouration	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Lacrimation increased	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Eye disorders Photophobia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Proteinuria	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	66.7% 2/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Haematuria	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 2/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Chromaturia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Dysuria	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Renal and urinary disorders Nocturia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	14.3% 1/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Ventricular arrhythmia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Bradycardia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Extrasystoles	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Mitral valve incompetence	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Palpitations	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Pulmonary valve incompetence	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Tachycardia	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	33.3% 1/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/1 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/2 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	— 0/0 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/1 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	50.0% 1/2 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/2 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Reproductive system and breast disorders Breast pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Reproductive system and breast disorders Gynaecomastia	— 0/0 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	— 0/0 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	16.7% 1/6 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	— 0/0 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/6 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/1 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/2 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	— 0/0 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/1 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/2 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/2 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	25.0% 1/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	10.0% 1/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	20.0% 1/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.
Hepatobiliary disorders Biliary colic	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/7 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/4 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	12.5% 1/8 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/3 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/5 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.	0.00% 0/10 • From the date of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 670 days for Part 1; 868 days for Part 2b; 825 days for Part 2e) Safety population included all participants treated with at least 1 dose of any study drug. One participant enrolled in Part 1 and 2 participants enrolled in Part 2b completed their initial enrollment and subsequently re-enrolled in Part 2e.

Additional Information

VP, Head of Clinical Development Operations

Cogent Biosciences, Inc.

Phone: 617-945-5576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60