Trial Outcomes & Findings for COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers (NCT NCT04392219)

NCT ID: NCT04392219

Last Updated: 2021-07-19

Results Overview

Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following a single dose of EIDD-2801 in Part 1

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 130 participants
• Primary outcome timeframe: From screening through study completion, up to 15 days
• Results posted on: 2021-07-19

Participant Flow

The same 10 participants started and completed the Part 200 mg EIDD-2801 (Fasted) and Part 200 mg EIDD-2801 (Fed) arms.

Participant milestones

Measure	Part 1 - Placebo Participants were randomized to receive a single oral dose of Placebo (fasted).	Part 1 - 50 mg EIDD-2801 Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 100 mg EIDD-2801 Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 200 mg EIDD-2801 Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 400 mg EIDD-2801 Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 600 mg EIDD-2801 Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 800 mg EIDD-2801 Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 1200 mg EIDD-2801 Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).	Part 1 - 1600 mg EIDD-2801 Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).	Part 2 - 200 mg EIDD-2801 (Fasted/Fed) Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed).	Part 3 - Placebo Participants were randomized to receive a twice daily dosing of Placebo capsules (fasted).	Part 3 - 50 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted).	Part 3 - 100 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted).	Part 3 - 200 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted).	Part 3 - 300 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted).	Part 3 - 400 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted).	Part 3 - 600 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted).	Part 3 - 800 mg EIDD-2801 Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted).
Overall Study STARTED	16	6	6	6	6	6	6	6	6	10	14	6	6	6	6	6	6	6
Overall Study COMPLETED	16	6	6	6	6	6	6	6	6	10	14	6	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers

Baseline characteristics by cohort

Measure	Part 1 - Placebo n=16 Participants Participants were randomized to receive a single oral dose of Placebo (fasted).	Part 1 - 50 mg EIDD-2801 n=6 Participants Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 100 mg EIDD-2801 n=6 Participants Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 200 mg EIDD-2801 n=6 Participants Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 400 mg EIDD-2801 n=6 Participants Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 600 mg EIDD-2801 n=6 Participants Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 800 mg EIDD-2801 n=6 Participants Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 1200 mg EIDD-2801 n=6 Participants Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).	Part 1 - 1600 mg EIDD-2801 n=6 Participants Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).	Part 2 - 200 mg EIDD-2801 (Fasted/Fed) n=10 Participants Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted/fed).	Part 3 - Placebo n=14 Participants Participants were randomized to receive two daily dosing of Placebo capsules (fasted).	Part 3 - 50 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 50 mg EIDD-2801 capsules (fasted).	Part 3 - 100 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 100 mg EIDD-2801 capsules (fasted).	Part 3 - 200 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 200 mg EIDD-2801 capsules (fasted).	Part 3 - 300 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 300 mg EIDD-2801 capsules (fasted).	Part 3 - 400 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 400 mg EIDD-2801 capsules (fasted).	Part 3 - 600 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 600 mg EIDD-2801 capsules (fasted).	Part 3 - 800 mg EIDD-2801 n=6 Participants Participants were randomized to receive two daily dosing of 800 mg EIDD-2801 capsules (fasted).	Total n=130 Participants Total of all reporting groups
Age, Continuous	39.4 years n=5 Participants	52.0 years n=7 Participants	41.2 years n=5 Participants	39.8 years n=4 Participants	42.0 years n=21 Participants	38.2 years n=10 Participants	39.5 years n=115 Participants	34.2 years n=24 Participants	30.8 years n=42 Participants	45.3 years n=42 Participants	37.5 years n=42 Participants	34.0 years n=42 Participants	45.5 years n=36 Participants	36.8 years n=36 Participants	36.2 years n=24 Participants	38.8 years n=135 Participants	30.8 years n=136 Participants	30.8 years n=44 Participants	38.7 years n=667 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	21 Participants n=667 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	7 Participants n=42 Participants	12 Participants n=42 Participants	5 Participants n=42 Participants	5 Participants n=36 Participants	6 Participants n=36 Participants	4 Participants n=24 Participants	5 Participants n=135 Participants	6 Participants n=136 Participants	6 Participants n=44 Participants	109 Participants n=667 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	4 Participants n=667 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	5 Participants n=115 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	9 Participants n=42 Participants	13 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=36 Participants	5 Participants n=36 Participants	5 Participants n=24 Participants	6 Participants n=135 Participants	6 Participants n=136 Participants	5 Participants n=44 Participants	122 Participants n=667 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	4 Participants n=667 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Body mass index	24.80 kg/m^2 STANDARD_DEVIATION 2.217 • n=5 Participants	26.07 kg/m^2 STANDARD_DEVIATION 2.649 • n=7 Participants	23.50 kg/m^2 STANDARD_DEVIATION 3.501 • n=5 Participants	26.68 kg/m^2 STANDARD_DEVIATION 2.320 • n=4 Participants	24.48 kg/m^2 STANDARD_DEVIATION 2.349 • n=21 Participants	25.32 kg/m^2 STANDARD_DEVIATION 1.847 • n=10 Participants	26.45 kg/m^2 STANDARD_DEVIATION 2.745 • n=115 Participants	25.15 kg/m^2 STANDARD_DEVIATION 1.623 • n=24 Participants	23.37 kg/m^2 STANDARD_DEVIATION 2.954 • n=42 Participants	25.38 kg/m^2 STANDARD_DEVIATION 2.185 • n=42 Participants	24.79 kg/m^2 STANDARD_DEVIATION 2.681 • n=42 Participants	22.27 kg/m^2 STANDARD_DEVIATION 3.371 • n=42 Participants	24.97 kg/m^2 STANDARD_DEVIATION 4.162 • n=36 Participants	25.50 kg/m^2 STANDARD_DEVIATION 3.117 • n=36 Participants	24.48 kg/m^2 STANDARD_DEVIATION 1.901 • n=24 Participants	24.32 kg/m^2 STANDARD_DEVIATION 2.866 • n=135 Participants	24.50 kg/m^2 STANDARD_DEVIATION 3.679 • n=136 Participants	24.20 kg/m^2 STANDARD_DEVIATION 2.504 • n=44 Participants	24.81 kg/m^2 STANDARD_DEVIATION 2.707 • n=667 Participants

PRIMARY outcome

Timeframe: From screening through study completion, up to 15 days

Population: Safety population

Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following a single dose of EIDD-2801 in Part 1

Outcome measures

Measure	Part 1 - Placebo n=16 Participants Participants were randomized to receive a single oral dose of Placebo (fasted).	Part 1 - 50 mg EIDD-2801 n=6 Participants Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 100 mg EIDD-2801 n=6 Participants Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 200 mg EIDD-2801 n=6 Participants Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 400 mg EIDD-2801 n=6 Participants Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 600 mg EIDD-2801 n=6 Participants Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 800 mg EIDD-2801 n=6 Participants Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 1200 mg EIDD-2801 n=6 Participants Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).	Part 1 - 1600 mg EIDD-2801 n=6 Participants Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events TEAEs (Overall)	7 Participants	2 Participants	0 Participants	3 Participants	3 Participants	4 Participants	2 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events Mild (Grade 1)	7 Participants	2 Participants	0 Participants	3 Participants	3 Participants	4 Participants	2 Participants	1 Participants	2 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events Moderate (Grade 2)	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events Severe (Grade 3)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From screening through study completion, up to 20 days

Population: Safety population

Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following multiple doses of EIDD-2801 in Part 3

Outcome measures

Measure	Part 1 - Placebo n=14 Participants Participants were randomized to receive a single oral dose of Placebo (fasted).	Part 1 - 50 mg EIDD-2801 n=6 Participants Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 100 mg EIDD-2801 n=6 Participants Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 200 mg EIDD-2801 n=6 Participants Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 400 mg EIDD-2801 n=6 Participants Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 600 mg EIDD-2801 n=6 Participants Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 800 mg EIDD-2801 n=6 Participants Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 1200 mg EIDD-2801 n=6 Participants Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).	Part 1 - 1600 mg EIDD-2801 Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).
Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events TEAEs (Overall)	7 Participants	2 Participants	3 Participants	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants	—
Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events Mild (Grade 1)	7 Participants	2 Participants	3 Participants	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants	—
Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events Moderate (Grade 2)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events Severe (Grade 3)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

Adverse Events

Part 1 - Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1 - 50 mg EIDD-2801

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1 - 100 mg EIDD-2801

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1 - 200 mg EIDD-2801

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1 - 400 mg EIDD-2801

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1 - 600 mg EIDD-2801

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1 - 800 mg EIDD-2801

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1 - 1200 mg EIDD-2801

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1 - 1600 mg EIDD-2801

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2 - 200 mg EIDD-2801 (Fasted)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2 - 200 mg EIDD-2801 (Fed)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 3 - Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 3 - 50 mg EIDD-2801

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 3 - 100 mg EIDD-2801

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 3 - 200 mg EIDD-2801

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 3 - 300 mg EIDD-2801

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 3 - 400 mg EIDD-2801

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 3 - 600 mg EIDD-2801

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 3 - 800 mg EIDD-2801

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1 - Placebo n=16 participants at risk Participants were randomized to receive a single oral dose of Placebo (fasted).	Part 1 - 50 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 50 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 100 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 100 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 200 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 200 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 400 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 400 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 600 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 600 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 800 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 800 mg EIDD-2801 powder-in-bottle (fasted).	Part 1 - 1200 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 1200 mg EIDD-2801 capsule (fasted).	Part 1 - 1600 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive 1600 mg EIDD-2801 capsule (fasted).	Part 2 - 200 mg EIDD-2801 (Fasted) n=10 participants at risk Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fasted).	Part 2 - 200 mg EIDD-2801 (Fed) n=10 participants at risk Participants were randomized to receive two single 200 mg oral doses of EIDD-2801 in an open-label manner (fed).	Part 3 - Placebo n=14 participants at risk Participants were randomized to receive twice daily dosing of Placebo capsules (fasted).	Part 3 - 50 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 50-mg EIDD-2801 capsules (fasted).	Part 3 - 100 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 100-mg EIDD-2801 capsules (fasted).	Part 3 - 200 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 200-mg EIDD-2801 capsules (fasted).	Part 3 - 300 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 300-mg EIDD-2801 capsules (fasted).	Part 3 - 400 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 400-mg EIDD-2801 capsules (fasted).	Part 3 - 600 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 600-mg EIDD-2801 capsules (fasted).	Part 3 - 800 mg EIDD-2801 n=6 participants at risk Participants were randomized to receive twice daily dosing of 800-mg EIDD-2801 capsules (fasted).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Ear and labyrinth disorders Ear pain	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Ear and labyrinth disorders Tinnitus	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Eye disorders Abnormal sensation in eye	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Eye disorders Eye irritation	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Eye disorders Ocular hyperaemia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Constipation	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Mouth ulceration	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Nausea	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Gastrointestinal disorders Vomiting	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Catheter site dryness	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Catheter site pain	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Feeling hot	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	33.3% 2/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Catheter site rash	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Influenza like illness	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Medical device site erythema	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Medical device site reaction	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
General disorders Pyrexia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Infections and infestations Nasopharyngitis	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Injury, poisoning and procedural complications Wound	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	33.3% 2/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Ageusia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Dizziness	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	10.0% 1/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Dizziness postural	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Headache	18.8% 3/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	50.0% 3/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	33.3% 2/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Hypersomnia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Paraesthesia	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Parosmia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Poor quality sleep	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Presyncope	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Somnolence	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	14.3% 2/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Nervous system disorders Taste disorder	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Psychiatric disorders Abnormal dreams	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Psychiatric disorders Insomnia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Renal and urinary disorders Chromaturia	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Renal and urinary disorders Pollakiuria	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	10.0% 1/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.2% 1/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Skin and subcutaneous tissue disorders Acne	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	16.7% 1/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Skin and subcutaneous tissue disorders Scab	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	10.0% 1/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.
Vascular disorders Hot flush	0.00% 0/16 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/10 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	7.1% 1/14 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.	0.00% 0/6 • From the time of the first study drug administration until the completion of the End of Study visit (Part 1: approximately 15 days, Part 2: approximately 30 days, and Part 3: approximately 20 days) Once each day while the participant was in the clinic and once during each out-patient visit, the principal investigator (or designee) inquired about the occurrence of adverse events. Open-ended questions may have been used to obtain this information.

Additional Information

Dr. Wendy Painter

Ridgeback Biotherapeutics

Phone: 786-687-2495

Email: EIDD2801@ridgebackbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI is required to obtain written consent from the Sponsor before anything relating to the study can be published.
• Publication restrictions are in place

Restriction type: OTHER